目錄 | | 頁次 | | --- | --- | | 公司資料 | 2 | | 財務摘要 | 4 | | 董事長致辭 | 5 | | 管理層討論及分析 | 6 | | 董事及高級管理層履歷 | 30 | | 董事會報告 | 35 | | 企業管治報告 | 64 | | 獨立核數師報告 | 78 | | 綜合損益表 | 83 | | 綜合損益及其他全面收益表 | 84 | | 綜合財務狀況表 | 85 | | 綜合權益變動表 | 87 | | 綜合現金流量表 | 89 | | 財務報表附註 | 90 | | 財務概要 | 159 | | 釋義 | 160 | 公司資料 董事會 執行董事 李靜女士 （董事會主席） Silvio Rudolf SCHAFFNER先生 （自2024年6月12日起調任為非執行董事） 非執行董事 Acotec Scientific Holdings Limited ( 於開曼群島註冊成立的有限公司 ) 股份代號 : 6669 2024 年度報告 Silvio Rudolf SCHAFFNER先生 （自2024年6月12日起調任為非執行董事） Arthur Crosswell BUTCH ...

Financial Performance - Revenue for the year ended December 31, 2024, was RMB 533.988 million, representing a year-on-year increase of 12.7% compared to RMB 473.848 million in 2023[3]. - Gross profit for the same period was RMB 402.722 million, up 6.7% from RMB 377.415 million in 2023[3]. - Profit before tax surged to RMB 52.601 million, a significant increase of 264.0% from RMB 14.452 million in the previous year[3]. - The net profit for the year was RMB 52,280 thousand, a significant increase from RMB 14,487 thousand in 2023, reflecting a growth of 261.5%[15][17]. - Basic and diluted earnings per share rose to RMB 0.17 from RMB 0.05, marking a 240% increase year-over-year[15]. - The company reported a total comprehensive income of RMB 53,288 thousand for the year, up from RMB 15,179 thousand in 2023[17]. - Revenue from external customers for 2024 reached RMB 533,988,000, an increase of 12.7% from RMB 473,848,000 in 2023[31]. - Revenue from mainland China accounted for RMB 508,787,000, up 11% from RMB 458,226,000 in 2023[31]. - Other income for 2024 was RMB 40,429,000, a rise of 14.4% from RMB 35,397,000 in 2023, driven by increased interest income[33]. - The company reported a revenue of approximately RMB 213.7 million from the sale of venous intervention, vascular access products, and other products, representing an annual increase of about 42.2%[104]. Research and Development - The company registered 11 patents and submitted 16 new patent applications during the reporting period[4]. - Research and development expenses increased to RMB 216,773 thousand from RMB 190,070 thousand, highlighting the company's commitment to innovation[15]. - The company plans to invest in technological innovation to strengthen its R&D capabilities and maintain its leading position in the DCB market[119]. - The company has a robust R&D team and has strengthened its talent pool by adding personnel with expertise in mechanical design, polymer materials, medicine, pharmacy, and chemistry[109]. - The company is investing in R&D for innovative technologies aimed at enhancing product efficacy and expanding market reach[169]. Product Development and Market Expansion - The company has expanded its international business, completing preliminary work for market entry in countries such as Chile, Austria, and the UK[8]. - A distribution agreement with Boston Scientific Group plc was established for the sale of peripheral DCB products in overseas markets[10]. - Seven products received approval from the National Medical Products Administration, enhancing the company's product portfolio and market influence[6]. - The company initiated clinical trials for AcoArt Litos® in the US and Europe, marking a significant milestone for market entry[65]. - The company plans to expand its product offerings across four treatment areas, including vascular surgery, cardiology, nephrology, and neurology, leveraging synergies from its four core technologies[153]. Operational Efficiency and Cost Management - Administrative expenses for the year ending December 31, 2024, were approximately RMB 64.9 million, a decrease of about 22.6% from RMB 83.8 million for the year ending December 31, 2023[135]. - Financing costs increased by approximately 15.5% to RMB 11.5 million for the year ending December 31, 2024, compared to RMB 10.0 million for the year ending December 31, 2023, primarily due to increased interest expenses[136]. - The company reported a decrease in operational costs by D%, which positively impacted overall profitability margins[171]. Future Outlook - The company plans to continue expanding its market presence and investing in new product development to drive future growth[22]. - The company provided an optimistic outlook for the next fiscal year, projecting revenue growth of B% and an expected increase in user engagement metrics[171]. - The company anticipates increased sales from overseas markets as its products and pipeline products gain more marketing approvals outside of China[112]. - Future guidance includes a commitment to maintaining a strong balance sheet while pursuing growth opportunities in emerging markets[171]. Intellectual Property and Regulatory Approvals - The company has a strong intellectual property portfolio, including 57 registered patents and 42 pending patent applications as of December 31, 2024[109]. - The company has received regulatory approval for AcoArt Orchid® & Dhalia® in multiple countries, including Germany, Italy, and Brazil, and is expanding into additional markets such as Chile and Austria[74]. - The coronary microcatheter (Vericor-S2®) received NMPA registration approval on January 20, 2025[76]. Employee and Talent Development - The total number of employees reached 650, with the R&D team growing to 131 members, enhancing the company's talent pool[13]. - The company has improved the design and coating process of its products to enhance treatment efficacy and operational convenience[103].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 292.3 million, representing a 20.3% increase compared to RMB 243.1 million for the same period in 2023[5]. - Gross profit for the same period was RMB 217.2 million, an increase of 11.3% from RMB 195.1 million year-on-year[5]. - Profit before tax surged to RMB 39.9 million, marking a significant increase of 78.7% from RMB 22.4 million in the previous year[5]. - The company reported a total comprehensive income of RMB 40,329,000 for the period, compared to RMB 23,890,000 in the previous year[89]. - Net profit for the period was RMB 39,957,000, a significant increase of 78.8% from RMB 22,369,000 in the previous year[89]. - Basic and diluted earnings per share for the period were both RMB 0.13, compared to RMB 0.07 in the same period last year[88]. - The company generated approximately RMB 174.6 million from core product sales, reflecting a year-on-year increase of about 14.2%[36]. - Revenue from diversified products, including peripheral suction systems and radiofrequency ablation systems, contributed approximately RMB 117.7 million, accounting for about 40.3% of total revenue[8]. Product Development and Innovation - The company has established approximately 30 product pipelines across vascular surgery, cardiology, nephrology, and neurology, focusing on minimally invasive interventional solutions[6]. - The product pipeline includes approximately 30 diverse products across vascular surgery, cardiology, nephrology, and neurology, demonstrating strong market potential and execution capabilities[9]. - The company registered six new patents and submitted six additional patent applications during the reporting period[7]. - AcoArt Litos® received FDA IDE approval in November 2023, marking a significant milestone for entry into the U.S. market, with clinical trials currently being prepared[9]. - Three products received approval from the National Medical Products Administration during the reporting period, including Peridge®, Wingyan®, and Vericor-RS®[12]. - The company is actively cultivating the market for new products to provide innovative treatment solutions for clinical patients[10]. - The company has a strong internal R&D team with 63 registered patents and 38 pending patent applications as of June 30, 2024[34]. Market Expansion and Strategic Partnerships - The company has expanded its international presence, preparing to enter markets in Chile, Austria, Finland, Sweden, the Netherlands, and the UK[8]. - A strategic cooperation agreement was signed with Boston Scientific Group plc to enhance product commercialization and development over the next three years[8]. - A framework agreement with BSG was established on July 20, 2023, to enhance global market sales opportunities for the company's products[40]. - The company aims to become a global leader in providing comprehensive interventional solutions for vascular diseases[39]. Financial Position and Resources - As of June 30, 2024, the total available financial resources amounted to approximately RMB 930.4 million, an increase of about 5.8% from RMB 879.4 million as of December 31, 2023[54]. - The total borrowings as of June 30, 2024, were RMB 55.0 million, up from RMB 10.0 million as of December 31, 2023, resulting in a capital debt ratio increase from approximately 24.3% to 27.8%[55]. - The net current assets as of June 30, 2024, were approximately RMB 1,113.4 million, an increase of about 1.7% from RMB 1,094.9 million as of December 31, 2023[56]. - The company plans to continue expanding in both domestic and global markets and will support capital expenditures through various financing channels, including internal funds and bank loans[62]. Operational Efficiency and Cost Management - The cost of sales for the six months ended June 30, 2024, was approximately RMB 75.1 million, a significant increase of about 56.7% from RMB 47.9 million in the previous year[43]. - Gross profit increased by approximately 11.3% to about RMB 217.2 million, but the gross margin decreased from 80.3% to 74.3% due to lower margins on certain products[44]. - Research and development costs rose by approximately 11.8% to RMB 100.5 million, driven by an increase in R&D personnel and ongoing project investments[48]. - Administrative expenses decreased by approximately 11.8% to RMB 33.8 million for the six months ended June 30, 2024, from RMB 38.3 million for the same period in 2023[50]. Shareholder Information and Corporate Governance - The company does not recommend an interim dividend for the six months ending June 30, 2024[66]. - The company intends to retain future profits for business operations and expansion, with no current plans for dividend distribution[67]. - As of June 30, 2024, Boston Scientific Group plc (BSG) holds 203,702,962 shares, representing 65% of the company's equity[76]. - The company has adopted a corporate governance code and has complied with all applicable provisions, except for the separation of the roles of Chairman and CEO[67].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 292,339,000, representing a 20.3% increase from RMB 243,063,000 for the same period in 2023[2] - Gross profit for the same period was RMB 217,210,000, up 11.3% from RMB 195,116,000 year-on-year[2] - Profit before tax increased significantly by 78.7% to RMB 39,939,000 compared to RMB 22,351,000 in the previous year[2] - Net profit for the period was RMB 39,957,000, reflecting a 78.6% increase from RMB 22,369,000 in the prior year[2] - Basic and diluted earnings per share for the period were both RMB 0.13, compared to RMB 0.07 in the same period last year[3] - Revenue for the reporting period was approximately RMB 292.3 million, representing a year-on-year increase of about 20.3%[33] - Revenue from diversified products, including AcoStream® and AcoArt Cedar®, contributed approximately RMB 117.7 million, accounting for about 40.3% of total revenue[35] - Revenue from AcoArt Orchid® & Dhalia® sales in China and overseas reached approximately RMB 142.3 million, representing a year-on-year increase of about 12.8%[43] - Revenue from AcoArt Tulip® & Litos® sales in China and overseas reached approximately RMB 32.3 million, representing a year-on-year increase of about 21.1%[44] - Revenue from venous intervention and vascular access products, including AcoArt Iris® & Jasmin®, AcoArt Lily® & Rosmarin®, and others, was approximately RMB 117.7 million, reflecting a year-on-year increase of about 30.5%[49] Research and Development - Research and development expenses rose to RMB 100,459,000, compared to RMB 89,877,000 in the same period last year[3] - Research and development costs for the six months ended June 30, 2024, were approximately RMB 100.5 million, an increase of about 11.8% from RMB 89.9 million in the same period of 2023[74] - The company has established a strong internal R&D team and has supplemented it with technical personnel in clinical medicine and mechanical engineering[59] - The company has registered six patents and submitted six new patent applications during the reporting period[33] - The company holds 63 registered patents and 38 pending patent applications as of June 30, 2024, along with 154 registered trademarks and 27 pending trademark applications[63] Assets and Liabilities - Total assets as of June 30, 2024, were RMB 1,304,145,000, compared to RMB 1,211,124,000 at the end of 2023[6] - The company's net asset value increased to RMB 1,336,857,000 from RMB 1,296,528,000 at the end of the previous year[9] - The total available financial resources of the group amounted to approximately RMB 930.4 million, an increase of about 5.8% from RMB 879.4 million as of December 31, 2023[80] - The total borrowings of the group as of June 30, 2024, were RMB 55.0 million, up from RMB 10.0 million as of December 31, 2023[81] - The capital debt ratio increased from approximately 24.3% as of December 31, 2023, to about 27.8% as of June 30, 2024, primarily due to the increase in bank loans[81] Corporate Governance - The company has adopted a corporate governance code and has complied with all applicable provisions during the reporting period, with the exception of the separation of the roles of Chairman and CEO, which are held by the same individual[88] - The board does not recommend the payment of an interim dividend for the six months ending June 30, 2024, consistent with the previous period where no dividend was declared[88] - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[88] - The board will continue to review the effectiveness of the corporate governance structure to assess the need for separating the roles of Chairman and CEO[88] Market Expansion and Product Development - The company has expanded its international business, preparing to enter markets in Chile, Austria, Finland, Sweden, the Netherlands, and the UK with AcoArt products[35] - The company has established strategic partnerships, including a comprehensive cooperation agreement with Boston Scientific Group plc to enhance product commercialization and development[35] - The company plans to expand its product offerings in four treatment areas: vascular surgery, cardiology, nephrology, and neurology, primarily by expanding the indications for DCB products[66] - The company aims to increase sales of products already in hospitals and will implement a systematic DCB training program to accelerate physician education[66] - The company has ongoing product pipeline updates to meet market demands, with several products expected to launch between 2024 and 2026[43] Employee and Operational Metrics - The total number of employees reached 615, with the R&D team growing from 127 to 132 members, enhancing the company's talent pool[37] - The group employed a total of 615 employees as of June 30, 2024, with a focus on competitive compensation and continuous training programs[83] - The production capacity, actual output, and utilization rate for commercial balloon catheter products during the reporting period were 466,644, 202,811, and 43.5% respectively[61] Financial Review and Audit - The interim financial report for the six months ending June 30, 2024, has not been audited but has been reviewed by KPMG according to the relevant standards[92] - The interim results announcement and the mid-year report for 2024 will be published on the Hong Kong Stock Exchange and the company's website[93]

Financial Performance - Total revenue for the year ended December 31, 2023, reached approximately RMB 473.8 million, a year-on-year increase of 19.8%[23] - Gross profit for the same period was approximately RMB 377.4 million, reflecting a year-on-year growth of 12.2%[23] - The company reported a significant decrease in profit before tax, down 79.4% to RMB 14.5 million from RMB 70.3 million in the previous year[23] - Adjusted net profit for the year was RMB 42.4 million, representing a year-on-year increase of 22.1%[23] - The company's revenue for the year ended December 31, 2023, was approximately RMB 473.8 million, an increase of about 19.8% compared to RMB 395.5 million for the year ended December 31, 2022[58] - Sales of core products, particularly AcoArt Tulip® and Litos®, contributed significantly to revenue growth, with core product sales reaching RMB 323.5 million, accounting for 68.3% of total revenue[59] - Revenue from venous intervention, vascular access, and other products increased by approximately 70.3%, rising from 22.3% of total revenue in 2022 to 31.7% in 2023[58] Product Development and Innovation - The company launched four new products in 2023, including the RT-Zero® coronary CTO balloon and AcoStream® second-generation peripheral thrombectomy system[27] - AcoArt Litos®, the world's first clinically validated below-the-knee drug-coated balloon, received FDA investigational device exemption (IDE) approval for clinical studies in the U.S.[27] - The company registered 19 new patents and submitted 26 new patent applications during the reporting period[30] - The company’s product pipeline includes over 30 products across various medical fields, with significant advancements in research and clinical trials in 2023[32] - The company received FDA IDE approval for clinical research of the BTK DCB in the United States, marking a significant milestone in its product development[32] - The company is advancing production development at a rapid pace, with significant progress in its product pipeline[35] - The company plans to commercialize 15 products by 2026, with several receiving regulatory approvals, including CE and NMPA certifications[35] Regulatory Approvals and Market Expansion - Four products received approval from the National Medical Products Administration during the reporting period, including two upgraded versions: AcoStream® II and ACOART AVENS®[34] - The coronary CTO recanalization balloon (RT-Zero®) and the coronary CTO antegrade microcatheter (Vericor-14®) further expand the company's product portfolio in the cardiology field[34] - The company is expanding the indications for AcoArt Orchid® & Dhalia® to include treatment for vertebral artery atherosclerotic stenosis, with expected regulatory approval in 2024[38] - The company anticipates obtaining regulatory approval for the peripheral scoring balloon in 2024, having submitted the product registration in 2023[45] - The company expects to obtain regulatory approval for the coronary rapamycin DCB in 2024, following the completion of clinical trials[47] Strategic Partnerships and Collaborations - The company established a strategic partnership with Boston Scientific, outlining collaboration in product commercialization, manufacturing services, and product development over the next three years[31] - A framework agreement was signed with BSG on July 20, 2023, to regulate ongoing related party transactions and facilitate global market sales of the company's products[56] - The cooperation agreement allows BSG to sell its products through the company in the Greater China region, and vice versa[128] Research and Development - The company has a strong internal R&D team with 66 registered patents and 30 pending applications as of December 31, 2023[51] - Research and development costs for the year ended December 31, 2023, were approximately RMB 1,901 million, a 3.4% increase from RMB 1,838 million for the year ended December 31, 2022, mainly due to an increase in the number of R&D personnel[63] - The company aims to enhance its R&D capabilities through increased investment in technological innovation to maintain its leading position in the DCB market[57] Financial Position and Liabilities - Non-current assets increased by 159.5% to RMB 399.9 million as of December 31, 2023, compared to RMB 154.1 million in 2022[25] - Total assets grew by 14.2% to RMB 1,611.1 million in 2023, up from RMB 1,410.5 million in 2022[25] - Total liabilities increased by 133.9% to RMB 314.5 million in 2023, compared to RMB 134.5 million in 2022[25] - The company's capital debt ratio increased from approximately 10.5% as of December 31, 2022, to approximately 24.3% as of December 31, 2023, mainly due to an increase in lease liabilities[72] Corporate Governance and Management - The board of directors consists of seven members, including two executive directors and three independent non-executive directors, ensuring a balanced governance structure[186] - The company has established three committees: audit committee, remuneration committee, and nomination committee, each with defined responsibilities[197] - The audit committee confirmed that the annual performance for the year ending December 31, 2022, complied with relevant accounting standards and regulations[199] Market Strategy and Sales - The company employs a strategic marketing model, leveraging relationships with hospitals and a KOL network to promote products in China[53] - The company is focusing on expanding its core products across three therapeutic areas, indicating a strategic approach to market growth[36] - The company aims to diversify its revenue sources through accelerated international business development, enhancing its ability to respond to market changes[78] Employee and Workforce Development - As of December 31, 2023, the company employed a total of 638 staff, with the R&D team growing to 127 members, enhancing its talent pool[33] - The company has implemented various internal occupational health and safety procedures to maintain a safe working environment[103] Shareholder and Equity Information - The total reserves available for distribution to equity shareholders as of December 31, 2023, amounted to RMB 1,341,822,000, a decrease from RMB 1,357,317,000 in 2022[107] - The company has confirmed the independence of all independent non-executive directors as of the report date[114] - The board does not recommend the distribution of a final dividend for the year ending December 31, 2023[80] Environmental and Social Responsibility - The company emphasizes its commitment to sustainable development and environmental responsibility in its operations[101] - The total amount of donations made by the group for the year ended December 31, 2023, was approximately RMB 1.83 million[177]

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 473.8 million, representing a year-on-year increase of 19.8% from RMB 395.5 million in 2022[2] - Gross profit for the same period was RMB 377.4 million, up 12.2% from RMB 336.4 million in the previous year[2] - Adjusted net profit for the year was RMB 42.4 million, an increase of 22.1% compared to RMB 34.8 million in 2022[2] - Operating profit decreased significantly to RMB 25,009 thousand from RMB 72,075 thousand, a decline of 65.3%[6] - Net profit for the year was RMB 14,487 thousand, down 79.3% from RMB 70,142 thousand in 2022[7] - Basic and diluted earnings per share were both RMB 0.05, compared to RMB 0.23 in the previous year, reflecting a decrease of 78.3%[6] - Total comprehensive income for the year was RMB 15,179 thousand, a decrease of 78.4% from RMB 70,204 thousand in 2022[8] - Revenue from new products, including the second-generation peripheral suction system and radiofrequency ablation systems, contributed approximately RMB 150.3 million, accounting for about 31.7% of total revenue[4] - Core product revenue reached RMB 323,536 thousand in 2023, up from RMB 307,283 thousand in 2022, representing a growth of 5.1%[16] - Revenue from vascular intervention, access products, and others increased significantly to RMB 150,312 thousand in 2023 from RMB 88,262 thousand in 2022, marking a growth of 70.5%[16] Product Development and Approvals - The company registered 19 new patents and submitted 26 new patent applications during 2023[3] - A total of four new products received approval from the National Medical Products Administration in 2023, including upgrades to existing products[4] - The company received FDA IDE approval for BTK DCB clinical research, marking a significant advancement in its product pipeline[48] - AcoArt Daisy® clinical trial showed a target vessel restenosis rate of 6.85%, significantly lower than the stent group, indicating strong clinical efficacy[48] - AcoArt Orchid® & Dhalia® received the latest registration certificate for the expanded indication for treating AVF stenosis from the National Medical Products Administration in July 2022[56] - The company has received regulatory approval for the AV scoring balloon (Peridge®) on January 30, 2024[54] - The second-generation peripheral suction system (AcoStream® II) received approval from the National Medical Products Administration in April 2023[6] - The PTA balloon (P-Conic®) was approved by the National Medical Products Administration in December 2022, with no significant adverse changes reported since then[6] - The coronary CTO recanalization balloon (RT-Zero®) received approval in March 2023, with no significant adverse changes reported since then[66] - The company has submitted product registration for the peripheral scoring balloon in 2023, expecting approval in 2024[6] Market Expansion and Collaborations - The company expanded its international business, achieving market approvals in Japan and Thailand, bringing its product commercialization to a total of 15 countries[5] - The company signed a comprehensive cooperation agreement with Boston Scientific Group plc, enhancing collaboration in product commercialization and development over the next three years[5] - The company has established distribution agreements for its peripheral DCB products in the European market and various coronary products in the Chinese market, enabling BSC to begin sales in the domestic market[78] - A framework agreement was signed with BSG on July 20, 2023, to facilitate global market sales of the company's products, promoting revenue diversification[79] - The company plans to continue expanding its product pipeline and market presence through internal development, mergers, and acquisitions, supported by various financing channels including internal funds and bank loans[102] Research and Development - The total number of employees reached 638, with the R&D team growing to 127 members, enhancing the company's talent pool[5] - R&D expenses amounted to RMB 190,070 thousand in 2023, slightly increasing from RMB 183,796 thousand in 2022, a growth of 3.5%[24] - The company is focused on the research and development of vascular disease treatment solutions, indicating ongoing investment in innovation and market expansion[12] - The company aims to enhance its R&D capabilities by increasing investment in technological innovation to strengthen its competitive position in the DCB market[79] - The company is committed to enhancing its product offerings in response to market needs[54] Financial Position and Assets - Current assets totaled RMB 1,094,879 thousand, while total assets less current liabilities amounted to RMB 1,494,812 thousand, an increase from RMB 1,311,870 thousand in 2022[10] - Non-current liabilities increased to RMB 198,284 thousand from RMB 35,781 thousand, primarily due to lease liabilities[11] - The company's equity attributable to shareholders rose slightly to RMB 1,296,528 thousand from RMB 1,276,089 thousand in 2022[11] - The group had cash and cash equivalents of approximately RMB 879.2 million as of December 31, 2023, a decrease of about 10.9% from RMB 986.5 million as of December 31, 2022, primarily due to increased operating and capital expenditures[96] - The total borrowings amounted to RMB 10.0 million as of December 31, 2023, compared to zero as of December 31, 2022[97] - The debt-to-equity ratio increased from approximately 10.5% as of December 31, 2022, to approximately 24.3% as of December 31, 2023, mainly due to an increase in lease liabilities[97] Corporate Governance and Future Plans - The board of directors did not recommend a final dividend for the year ended December 31, 2023[43] - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[110] - The audit committee has reviewed the audited consolidated financial statements for the year and confirmed they were prepared in accordance with applicable accounting standards and regulations[112] - The annual performance announcement and the 2023 annual report will be published on the Stock Exchange and the company's website[113] - The company will continue to participate in international vascular intervention conferences and academic activities to promote its products and brand globally[107]

Financial Performance - Revenue for the six months ended June 30, 2023, reached RMB 243.1 million, an increase of 38.6% compared to RMB 175.3 million for the same period in 2022[7]. - Gross profit for the same period was RMB 195.1 million, reflecting a growth of 34.8% from RMB 144.8 million year-on-year[7]. - Adjusted net profit for the period was RMB 35.7 million, an increase of 83.8% compared to RMB 19.4 million in the previous year[7]. - Revenue from sales of AcoArt Orchid® & Dhalia® in China and overseas was approximately RMB 126.2 million, an increase of about 2.0% year-on-year[19]. - Revenue from sales of venous intervention and vascular access products was approximately RMB 88.9 million, an increase of about 190.9% year-on-year[25]. - Revenue from core products and venous intervention products was approximately RMB 152.9 million and RMB 88.9 million, representing increases of approximately 7.0% and 190.9%, respectively[41]. - The gross profit increased by approximately 34.8% to about RMB 195.1 million for the six months ended June 30, 2023, with a gross margin of approximately 80.3%, down from 82.6% in the same period of 2022[47]. - The company recorded a net loss of approximately RMB 7.1 million in other income for the six months ended June 30, 2023, compared to a net gain of RMB 15.1 million in the same period of 2022, primarily due to foreign exchange losses[49]. - The company reported a total comprehensive income of RMB 23,890 thousand for the period, compared to RMB 31,189 thousand in the same period last year[94]. Product Development and Innovation - The company is focused on continuous innovation and clinical promotion in vascular intervention therapies, aiming to provide new treatment solutions[10]. - The product pipeline is progressing as planned, with ongoing developments in various therapeutic areas[11]. - The company has a total of 14 commercialized products and 18 products under development, categorized as Class I, II, and III medical devices by the National Medical Products Administration[14]. - The company aims to enhance its global market reputation and expand revenue sources through the framework agreement with BSC[12]. - The company plans to expand its product offerings in five treatment areas, including vascular surgery, cardiology, nephrology, neurology, and urology, by broadening the indications for DCB products[43]. - The company is focused on expanding its core products and commercializing them in new markets[16]. - The company is developing a peripheral thrombectomy device, with expected NMPA approval in 2025[27]. - The company is developing a coronary IVL system aimed at reducing stent implantation rates, with expected NMPA approval in 2026[32]. Market Expansion and Internationalization - The company has successfully expanded its hospital admissions, with ATK DCB reaching 1,501 hospitals and BTK DCB reaching 750 hospitals as of June 30, 2023[9]. - The company has commercialized its products in 14 overseas countries, enhancing revenue diversification and market adaptability[9]. - The company aims to accelerate its internationalization process to further diversify its business and revenue sources[9]. - As of June 30, 2023, AcoArt Orchid® has been launched in 14 countries, including Germany, Italy, Switzerland, and Brazil, following regulatory approvals[18]. - The company has successfully launched AcoArt Tulip® & Litos® in 12 additional countries as of June 30, 2023[20]. Research and Development - Research and development costs for the six months ended June 30, 2023, were approximately RMB 89.9 million, an increase of about 16.6% compared to RMB 77.1 million for the same period in 2022[51]. - The company continues to focus on the research and development of treatment solutions for vascular diseases as its primary business[105]. - The company has been engaged in research and development of treatment solutions for vascular diseases, with its main operational location in Beijing, China[102]. Corporate Governance and Shareholder Information - The company has adopted a corporate governance code and has complied with all applicable provisions, except for the separation of the roles of Chairman and CEO[72]. - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[72]. - Boston Scientific became the controlling shareholder of the company with a 65% stake as of February 9, 2023, following a partial offer to shareholders[151]. - The company has entered into a total cooperation agreement and a total service agreement with its controlling shareholder, BSG, which holds approximately 65.0% of the company's issued share capital[66]. Financial Position and Cash Flow - Cash and cash equivalents as of June 30, 2023, were approximately RMB 947.8 million, a decrease of about 3.9% from RMB 986.5 million as of December 31, 2022[60]. - The capital-to-debt ratio increased from approximately 10.5% as of December 31, 2022, to about 22.9% as of June 30, 2023, primarily due to an increase in lease liabilities[61]. - The company reported a net cash generated from operating activities for the six months ended June 30, 2023, is RMB 9,918 thousand, a significant improvement from RMB (36,707) thousand for the same period in 2022[101]. - The company incurred RMB 25,733 thousand in payments for the purchase of property, plant, and equipment, and intangible assets during the first half of 2023, compared to RMB 17,335 thousand in the same period of 2022[101]. - The company’s total equity as of June 30, 2023, is RMB 1,276,089 thousand, an increase from RMB 1,225,309 thousand as of December 31, 2022, representing a growth of approximately 4.1%[99]. Employee and Training Initiatives - The total number of employees as of June 30, 2023, was 645, with ongoing efforts to enhance team capabilities and professional skills[10]. - The company has established a comprehensive training system to support employee growth and skill enhancement[10]. Regulatory Approvals and Compliance - Four products received approval from the National Medical Products Administration in the first half of 2023, including the second-generation peripheral suction system (AcoStream® II) and two cardiac products (RT-Zero® and Vericor-14®)[13]. - The company is exempt from clinical trial requirements based on the revised catalog issued by the NMPA[16]. - The company has received registration approval from the Thai Food and Drug Administration for the peripheral support catheter (Vericor®)[13].

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所產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Acotec Scientific Holdings Limited 先瑞達醫療科技控股有限公司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） （股 份 代 號：6669） 截 至2022年12月31日止年度年報的補充公告 茲提述先瑞達醫療科技控股有限公司（「本公司」）於2023年4月24日刊發的截至 2022年12月31日止年度的年度報告（「年 報」）。除 本 公 告 另 有 界 定 者 外，本 公 告 所 使 用 詞 彙 與 年 報 中 所 界 定 者 具 有 相 同 涵 義。除 本 公 司 於 年 報 中 所 作 披 露 外，本 公 司 謹 此 提 供 以 下 有 關 本 公 司 受 限 制 股 份 單 位 計 劃 及 股 份 獎 勵 計 劃 的 資 料。 受限制股份單位計劃 下表載列於報告期內根據受限制股份單位計劃授予承授人的 ...

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 243,063 thousand, representing a 38.6% increase from RMB 175,322 thousand in the same period of 2022[2] - Gross profit for the same period was RMB 195,116 thousand, up 34.8% from RMB 144,770 thousand year-on-year[2] - Profit before tax decreased by 28.6% to RMB 22,351 thousand compared to RMB 31,290 thousand in the previous year[2] - Net profit for the period was RMB 22,369 thousand, down 28.1% from RMB 31,096 thousand in the prior year[2] - Adjusted net profit increased by 83.8% to RMB 35,715 thousand from RMB 19,430 thousand year-on-year[2] - The company reported a total comprehensive income of RMB 23,890 thousand for the period, compared to RMB 31,189 thousand in the previous year[6] - The company reported external customer revenue from mainland China of RMB 236,974,000, a 38.5% increase from RMB 171,048,000 in the prior year[20] - The company reported a net loss of RMB 8,086,000 in foreign exchange gains/losses for the six months ended June 30, 2023, compared to a gain of RMB 15,152,000 in the same period of 2022[24] - The total finance costs for the six months ended June 30, 2023, amounted to RMB 4,357,000, significantly higher than RMB 866,000 in the previous year[25] - The company recorded a net other loss of approximately RMB 7.1 million for the six months ended June 30, 2023, compared to a net other income of RMB 15.1 million for the same period in 2022, primarily due to foreign exchange losses[80] Assets and Liabilities - Non-current assets increased significantly, with property, plant, and equipment valued at RMB 87,100 thousand, up from RMB 68,928 thousand[7] - Current assets totaled RMB 1,229,104 thousand, slightly down from RMB 1,256,438 thousand at the end of 2022[7] - Total equity attributable to shareholders increased to RMB 1,305,239 thousand from RMB 1,276,089 thousand[10] - The total non-current assets as of June 30, 2023, were RMB 339,840,000, compared to RMB 129,769,000 as of December 31, 2022[18] - Trade receivables, net of loss provisions, stood at RMB 116,507,000 as of June 30, 2023, compared to RMB 131,909,000 at the end of 2022[34] - The total amount of trade and other payables decreased to RMB 57.111 million from RMB 74.090 million as of December 31, 2022[35] - Cash and cash equivalents as of June 30, 2023, were approximately RMB 947.8 million, a decrease of about 3.9% from RMB 986.5 million as of December 31, 2022[92] - The net current assets of the group were approximately RMB 1,141.0 million as of June 30, 2023, a decrease of about 1.4% from RMB 1,157.8 million as of December 31, 2022[94] - The capital-to-debt ratio increased from approximately 10.5% as of December 31, 2022, to about 22.9% as of June 30, 2023, primarily due to an increase in lease liabilities[93] Research and Development - Research and development expenses rose to RMB 89,877 thousand, compared to RMB 77,070 thousand in the same period last year[4] - The company operates primarily in the blood-related disease treatment solutions sector, focusing on research and development[15] - The company is actively advancing its product pipeline, focusing on arterial diseases, venous diseases, and vascular tumors[43] - R&D expenses for the six months ended June 30, 2023, were approximately RMB 89.9 million, an increase of about 16.6% compared to RMB 77.1 million for the same period in 2022[82] - Employee benefits accounted for 44.6% of R&D expenses in 2023, up from 37.5% in 2022, reflecting increased personnel costs[83] - The company aims to enhance its R&D capabilities by increasing investment in technological innovation to strengthen its competitive position in the DCB market[73] Product Development and Approvals - In the first half of 2023, the company received approvals for four products from the National Medical Products Administration, enhancing its market presence[45] - The second-generation peripheral suction system (AcoStream®) was launched, offering improved therapeutic effects and ease of use compared to the first generation[45] - The company obtained approvals for two cardiac products: the coronary CTO recanalization balloon (RT-Zero®) and the coronary CTO retrograde microcatheter (Vericor-14®)[45] - The company’s paclitaxel-coated high-pressure balloon (ACOART AVENS®) received approval, strengthening its influence in the renal field[45] - The company has a total of 14 commercialized products and 18 products in development across three therapeutic areas[46] - The company is expanding the indications for AcoArt Orchid® & Dhalia® in treating vertebral artery atherosclerotic stenosis, with RCT enrollment completed in 2022 and expected approval in 2024[49] Market and Sales Performance - Revenue from core products, specifically drug-coated balloons (DCB), was RMB 152,874,000, up from RMB 142,898,000, indicating a growth of 7.4%[16] - Revenue from vascular intervention and access products surged to RMB 88,939,000, a significant increase from RMB 30,575,000, reflecting a growth of 190.5%[16] - Other commercialized products, including AcoStream® and AcoArt Cedar®, generated approximately RMB 88.9 million in revenue, accounting for about 36.6% of total revenue during the reporting period[40] - Sales from core products AcoArt Orchid® & Dhalia® and AcoArt Tulip® & Litos® generated approximately RMB 152.9 million, reflecting a year-on-year increase of about 7.0%[71] - Sales from venous intervention and vascular access products amounted to approximately RMB 88.9 million, with a significant year-on-year increase of about 190.9%[71] Corporate Governance and Strategy - The company maintains a high level of corporate governance to protect shareholder interests and enhance corporate value[105] - The board believes that the current structure, with the same individual serving as both Chair and CEO, ensures effective leadership and strategic planning[105] - The company plans to retain all future profits for business operations and expansion, with no current dividend policy in place[105] - The company is exploring strategic acquisitions to bolster its market position[112] - The company has strengthened its talent pool in hardware design, engineering, and materials science during the reporting period[70] Future Outlook - Future outlook includes expansion in the market and potential new product launches[112] - The company has set performance guidance for the upcoming quarters, anticipating growth in revenue[112] - The company expects to generate more cash from operating activities through increased sales of existing commercialized products and the launch of new products[92] - The company plans to expand its product offerings in five therapeutic areas, including vascular surgery, cardiology, nephrology, neurology, and urology, by increasing the indications for DCB products[73]

Financial Performance - For the fiscal year ending December 31, 2022, the total revenue was approximately RMB 395.5 million, representing a year-on-year increase of 30.2%[6] - Gross profit for the same period was approximately RMB 336.4 million, with a year-on-year growth of 26.5%[6] - The net profit for the year was approximately RMB 70.1 million, a significant recovery from a loss of RMB 79.1 million in the previous year[6] - The company achieved a revenue of approximately RMB 395.5 million in 2022, representing a year-on-year increase of about 30.2%[12] - Revenue from AcoArt Orchid® & Dhalia® sales in China and overseas was approximately RMB 270.8 million, representing a decrease of about 1.5% year-on-year[23] - Revenue from core products and venous intervention products was approximately RMB 307.3 million and RMB 86.0 million, representing increases of approximately 2.7% and 1,763.8%, respectively[40] - The company's revenue for the year ended December 31, 2022, was approximately RMB 395.5 million, an increase of about 30.2% compared to RMB 303.8 million for the year ended December 31, 2021[44] Product Development and Innovation - The company received approval for five new products and one DCB product indication expansion from the National Medical Products Administration in 2022[8] - The company has submitted 18 patent applications during the reporting period, with 4 applications already approved[12] - The company has launched five new products and received NMPA registration approvals for these products during the reporting period[16] - The company has expanded its product coverage to include cardiology, nephrology, and neurology, in addition to peripheral vascular diseases[12] - The company is focused on accelerating its internationalization process to diversify its revenue sources and respond flexibly to market changes[12] - The company is expanding the indications for AcoArt Orchid® & Dhalia® in treating vascular-related erectile dysfunction[25] - The company is expanding its core products AcoArt Orchid® & Dhalia® and AcoArt Tulip® & Litos® for the treatment of vascular erectile dysfunction, with expected regulatory approval in 2025[38] Financial Position and Assets - Total assets as of December 31, 2022, were RMB 1.41 billion, a 7.9% increase from the previous year[7] - Total liabilities increased by 34.2% to RMB 134.5 million, with current liabilities rising by 12.0%[7] - The total equity amounted to RMB 1.28 billion, reflecting a 5.7% increase year-on-year[7] - Cash and cash equivalents as of December 31, 2022, were approximately RMB 986.5 million, a decrease of about 13.3% from RMB 1,137.2 million in 2021, attributed to increased operating and investment expenditures[61] - The company's total borrowings were zero as of December 31, 2022, down from approximately RMB 6.0 million in the previous year[62] - The debt-to-equity ratio increased from approximately 8.3% in 2021 to about 10.5% in 2022[62] Research and Development - The company’s R&D team has grown to 118 members, enhancing its talent pool in various technical fields[14] - Research and development expenses for the year ended December 31, 2022, were approximately RMB 183.8 million, an increase of about 30.1% from RMB 141.3 million in 2021, driven by the acquisition of R&D centers and increased investment in ongoing projects[51] - The company is committed to clinical research and development to advance its product offerings and improve patient outcomes[90] Market Expansion and Strategy - The company aims to become a global leader in vascular disease intervention solutions, planning to expand DCB product indications across five treatment areas[43] - The company plans to enhance sales efforts for AcoArt Orchid® & Dhalia® and improve awareness of DCB products among patients in China[43] - The company intends to accelerate clinical development and commercialization of late-stage products while expanding sales penetration globally, particularly in Europe and the United States[43] - The company plans to continue expanding in both domestic and global markets and will support capital expenditures through various financing channels, including internal funds and bank loans[66] Governance and Management - The board of directors consists of seven members, including two executive directors and three independent non-executive directors, ensuring a balanced governance structure[157] - The company emphasizes high corporate governance standards and has adopted the principles and code provisions of the corporate governance code as per the listing rules[155] - The company has established three committees: the audit committee, the remuneration committee, and the nomination committee, each with defined responsibilities and reporting to the board[167] - The company has implemented various occupational health and safety procedures to maintain a safe working environment, with no significant claims or disputes reported[98] Risks and Compliance - The company faced significant risks including the lengthy and costly clinical product development process, which may lead to additional costs or delays[95] - The company has established various risk management procedures and internal control processes across major business and functional departments, including sales, procurement, and financial management[178] - The company has ensured that all directors confirmed compliance with the code of conduct regarding securities trading during the reporting period[180] Shareholder Relations - The company emphasizes the importance of effective communication with shareholders to enhance investor relations and ensure transparency in financial disclosures[184] - The company has set up various communication channels to respond to stakeholder inquiries effectively[193] - The board of directors will regularly review the company's status and consider adopting a dividend policy at an appropriate time[194]