Financial Performance - For the first half of 2024, the company reported revenue of RMB 128.5 million, representing a year-on-year increase of 17.2%[6] - Gross profit was RMB 82.3 million, with a gross margin of 64.0%, down 8.7 percentage points compared to the same period last year[6] - The company narrowed its pre-tax loss to RMB 3.2 million, a 94.1% improvement year-on-year[6] - Revenue increased by 17.2% from RMB 109.6 million for the six months ended June 30, 2023, to RMB 128.5 million for the six months ended June 30, 2024, driven by sales growth in acute ischemic stroke devices and intracranial artery stenosis treatment devices[19] - Gross profit rose from RMB 79.7 million to RMB 82.3 million, but gross margin decreased from 72.7% to 64.0% due to price pressures from volume-based procurement and market competition[21] - The net loss for the six months ended June 30, 2024, was RMB 5,119 thousand, significantly reduced from a net loss of RMB 54,338 thousand in 2023[69] - Basic and diluted loss per share improved to RMB (0.14) from RMB (1.42) year-over-year[69] Research and Development - The company invested RMB 31.8 million in R&D, focusing on diversifying neuro-interventional devices[7] - Research and development costs decreased significantly from RMB 69.9 million to RMB 31.8 million, attributed to reduced raw material costs and a decrease in the number of R&D personnel[23] - The company is focusing on R&D and has incurred RMB 31,752 thousand in R&D expenses for the six months ended June 30, 2024[69] - Research and development expenses increased by 30% to RMB 200 million, focusing on innovative medical technologies[109] Product Development and Market Expansion - Neuro-interventional devices contributed 35.6% of total sales, generating revenue of RMB 45.8 million[7] - The company plans to launch at least five major neuro-interventional devices in the next 18 months, including innovative drug-eluting balloon catheters and self-expanding drug stents[7] - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials[11] - The company is evaluating opportunities for expanding the Captor product's indications and potential overseas marketing[10] - The company plans to enhance brand awareness as a comprehensive provider of neuro-interventional devices and expand sales of commercialized products[17] - The company aims to develop innovative medical devices in emerging treatment areas to create a competitive product portfolio beyond its neuro-interventional business[17] - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[109] - A strategic acquisition of a local competitor is anticipated to enhance the company's product offerings and market reach[109] Regulatory and Compliance - The company has obtained CE or FDA certification for several products and is expanding its registration efforts in over ten other countries[7] - The company has 29 medical device products approved by NMPA, 3 products approved by FDA, and 1 product with CE mark as of the mid-term report date[6] - The company has adopted a code of conduct for trading its securities, confirming compliance by all directors and supervisors during the six months ended June 30, 2024[55] - The company has adhered to the corporate governance code, with all provisions complied with during the six months ended June 30, 2024, except for one[56] - The independent auditor, Ernst & Young, reviewed the group's interim financial data for the same period, ensuring accuracy and compliance[58] Shareholder Information and Incentive Plans - The 2021 H-share incentive plan was adopted on November 1, 2021, and has a validity period of ten years, with approximately 7.5 years remaining[41] - A total of 3,000,000 H-shares are allocated for three-year rewards, with a maximum of 30% vesting in the first year[43] - The plan is designed to align the interests of the leadership with those of shareholders and the overall group[38] - The company continues to implement its 2021 H-share incentive plan to align management interests with shareholder value[62] - The total number of shares available for the 2021 H-share incentive plan is 3,000,000, accounting for approximately 9.5% and 7.7% of the company's total H-share and issued share capital as of the report date[48] Cash Flow and Financial Position - Cash and bank balances as of June 30, 2024, were RMB 613.3 million, a decrease of RMB 8.9 million from RMB 622.2 million as of December 31, 2023[28] - The company reported a net cash flow from operating activities of RMB 8,799 thousand, a significant improvement from a net outflow of RMB 70,167 thousand in the same period of 2023[73] - The company reported an increase in cash and cash equivalents, totaling RMB 613,346 thousand at the end of the period, up from RMB 676,005 thousand in the previous year[74] - The company’s total cash and cash equivalents at the beginning of the period were RMB 605,583 thousand, with a net effect of exchange rate changes of RMB 454 thousand[74] Corporate Governance - The board consists of three non-executive directors, three independent non-executive directors, and three executive directors, ensuring a high level of independence[58] - The company plans to continue reviewing and monitoring its corporate governance standards to maintain high standards[58] - The audit committee, comprising independent non-executive directors, has reviewed the accounting principles and practices adopted by the group[58] - The company emphasizes the importance of internal controls and risk management in its financial reporting processes[58] Market Performance and User Engagement - User data showed an increase in active users by 15%, reaching a total of 3 million active users by June 30, 2024[109] - The company expects revenue growth to continue at a rate of 20% for the second half of 2024, driven by new product launches and market expansion[109] - Gross margin improved to 60%, up from 55% in the previous year, due to cost optimization strategies[109] - The company has launched two new products in Q2 2024, contributing to a 5% increase in overall sales[109]

Financial Performance - The company reported revenue of RMB 128.5 million for the first half of 2024, representing a year-on-year increase of 17.2%[2]. - Gross profit was RMB 82.3 million, with a gross margin of 64.0%, down 8.7 percentage points compared to the same period in 2023[2][3]. - The company narrowed its pre-tax loss to RMB 3.2 million, a decrease of 94.1% year-on-year[2][3]. - Revenue from customer contracts for the six months ended June 30, 2024, was RMB 128,484,000, an increase of 17.2% compared to RMB 109,586,000 for the same period in 2023[15]. - Revenue from medical device sales contributed RMB 128,484,000, with RMB 125,081,000 coming from mainland China, reflecting a growth from RMB 109,269,000 in the previous year[15]. - Other income for the six months ended June 30, 2024, totaled RMB 9,036,000, a decrease from RMB 10,746,000 in the same period of 2023[16]. - Interest income decreased to RMB 4,349,000 from RMB 6,433,000 year-over-year[16]. - Gross profit increased from RMB 79.7 million for the six months ended June 30, 2023, to RMB 82.3 million for the six months ended June 30, 2024, while gross margin decreased from 72.7% to 64.0% due to price impacts from volume-based procurement and market competition[36]. Research and Development - Research and development costs amounted to RMB 31.8 million, significantly reduced by 54.5% compared to the previous year[2][3]. - R&D expenses significantly decreased from RMB 69.9 million to RMB 31.8 million, attributed to reduced raw materials and consumables, a decrease in R&D team size, and lower third-party contracting costs[38]. - The company expects to launch at least five major neuro-interventional devices in the next 18 months, including innovative drug-eluting balloon catheters and self-expanding drug stents[3]. - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials, aimed at preventing vascular occlusion[27]. Sales and Distribution - Neuro-interventional devices contributed 35.6% of total sales, generating revenue of RMB 45.8 million[3]. - Sales from neurointerventional devices contributed 35.6% of total revenue, amounting to RMB 45.8 million[23]. - The sales of neurointerventional access devices and other products grew by 42.1% year-on-year to RMB 82.7 million[23]. - The company has established a distribution network covering over 2,000 hospitals across all provinces in China, excluding Hong Kong and Macau[30]. Financial Position - Total assets amounted to RMB 1,133.8 million, with net assets of RMB 1,069.98 million[6]. - Inventory increased to RMB 150.5 million, while trade receivables rose to RMB 85.0 million as of June 30, 2024[5]. - Trade receivables as of June 30, 2024, were RMB 85.0 million, compared to RMB 76.9 million as of December 31, 2023[21]. - Trade payables increased to RMB 5.7 million as of June 30, 2024, from RMB 3.7 million as of December 31, 2023[22]. - As of June 30, 2024, the company had no outstanding borrowings, and the debt-to-equity ratio remained stable at 3.4%[43]. - Cash and bank balances as of June 30, 2024, were RMB 613.3 million, a decrease of RMB 8.9 million from RMB 622.2 million as of December 31, 2023[44]. Corporate Governance - The company has adopted the corporate governance code to enhance management standards and protect shareholder interests[55]. - The audit committee consists of three members, including two independent non-executive directors, ensuring compliance with listing rules[56]. - The independent auditor has reviewed the group's interim financial data for the six months ending June 30, 2024[57]. - The board of directors is composed of three non-executive directors, three independent non-executive directors, and three executive directors, ensuring a high level of independence[55]. - The company emphasizes the importance of separating the roles of chairman and CEO, although both roles are currently held by the same individual[55]. - The company is committed to continuously reviewing and monitoring its corporate governance practices[55]. Future Plans - Plans to apply for A-share listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board to support future growth[32]. - The company aims to enhance its brand recognition as a comprehensive provider of neurointerventional devices and expand sales of commercialized products[32]. - The company is evaluating opportunities for overseas marketing of the Captor® device and may apply for registration in the United States[25].

Financial Performance - In 2023, the company achieved revenue of RMB 232.3 million, a 27% increase from RMB 183.0 million in 2022[8]. - The net loss for 2023 was RMB 94.0 million, a 53.1% reduction compared to RMB 200.4 million in 2022[8]. - Revenue increased by 26.9% from RMB 183.0 million in 2022 to RMB 232.3 million in 2023, driven by growth in therapeutic device sales[33]. - In fiscal year 2023, the company's revenue increased to RMB 232.3 million, representing a year-on-year growth of 26.9%, while the pre-tax loss narrowed to RMB 102.9 million, a decrease of 48.9%[13]. - Gross profit rose from RMB 124.3 million in 2022 to RMB 163.8 million in 2023, with gross margin improving from 67.9% to 70.5%[35]. Product Development and Innovation - Revenue from therapeutic devices reached nearly RMB 100 million, growing by 62.9%, with its revenue share increasing from 33.0% in 2022 to 42.3% in 2023[9]. - The company plans to launch at least 5 new therapeutic devices in the next 24 months, including products for aneurysm treatment and intracranial artery stenosis[9]. - The company aims to continue increasing the revenue share of therapeutic neurointerventional devices and optimize its research pipeline[10]. - Research and development costs for 2023 amounted to RMB 123.8 million, aimed at supporting a diverse pipeline of neurointerventional therapeutic devices[14]. - The company anticipates launching at least five major neurointerventional therapeutic devices in the next 24 months, including drug-coated balloons and self-expanding drug stents[14]. Regulatory Approvals and Certifications - The company registered 28 products with NMPA over the past three years, with applications in over 1,500 hospitals in China[8]. - Three products received FDA certification, and the thrombectomy stent obtained CE MDR certification, expanding the company's overseas market presence[9]. - As of the report date, the company has 28 devices approved by NMPA, three devices approved by FDA, and one device with CE mark[15]. - The Captor® thrombectomy device, the first of its kind approved by NMPA, has been upgraded to include various models for different vessel sizes and thrombus dimensions[18]. Operational Efficiency and Cost Control - The gross profit margin for products improved to 70.5%, while the selling and administrative expense ratio decreased to 66.2%, down by 25.6 percentage points year-on-year[9]. - The company is focusing on enhancing operational efficiency and cost control measures to improve profitability[10]. Market Expansion and Sales Strategy - The company is expanding its sales channels in overseas markets, with product registrations ongoing in ten additional countries[14]. - The company aims to become a leader in the Chinese neurointerventional medical device market and plans to enhance brand recognition and expand commercialization of its products[29][31]. Corporate Governance and Management - The company has expanded its board with independent non-executive directors who bring extensive experience in investment banking and financial management[79][80]. - The board's composition reflects a commitment to governance and strategic oversight, leveraging the diverse backgrounds of its members[80][82]. - The company has established policies and practices regarding corporate governance and compliance with legal and regulatory requirements[145]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a high level of independence[107]. Environmental Responsibility - The group aims to minimize negative impacts on the environment and strictly adheres to various environmental protection laws and regulations[192]. - The total emissions of waste gas in 2023 were approximately 29.7 kg, with a density of 12.7 kg per RMB 100 million in revenue, a 24.9% decrease compared to 2022[193]. - The company has implemented strict measures to comply with environmental regulations, ensuring that all waste gases are treated effectively before discharge[200]. - Regular monitoring of waste gas emissions is conducted by third-party testing agencies, with no instances of exceeding emission standards reported[200]. Future Outlook and Strategic Goals - The company has set ambitious performance guidance for the upcoming fiscal year, aiming for a revenue growth of over 15%[66]. - The company is exploring potential mergers and acquisitions to strengthen its market position and diversify its product portfolio[68]. - The long-term business model focuses on continuously launching innovative medical devices to redefine care standards and improve patient outcomes[98].

智通财经APP讯，心玮医疗-B(06609)发布截至2023年12月31日止年度业绩，该集团期内取得收益2.32亿元(人民币，下同)，同比增加26.9%;母公司拥有人应占亏损9401.2万元，同比收窄53.08%;每股基本亏损2.47元。 为了适应瞬息万变的市场环境及行业集采的推进，公司不断推动神经介入业务向治疗类器械聚焦的升级。取栓支架及抽吸导管，扩张球囊及栓塞保护系统，以及弹簧圈等神经介入治疗类器械贡献了42.3%的销售收入(2022年：33.0%)，收入金额同比增长62.9%至9820万元;神经介入通路器械及其他产品同比增长9.3%至1.34亿元。 公司研发成本为1.24亿元，用于支持神经介入治疗类器械的多元化在研项目。未来24个月，公司预期将有至少5款重磅神经介入治疗类器械上市，包括用于狭窄治疗的药物球囊(NMPA创新器械资质)、自膨式药物支架以及颈动脉支架，用于出血性卒中治疗的动脉瘤栓塞辅助支架(NMPA创新器械资质)以及血流导向装置。同时，公司针对不同亚型脑梗死的急诊手术需求，提升关键取栓产品(抽吸导管及取栓支架)及一站式医疗器械解决方案的竞争力，以满足老龄化背景下，中国市场日益增长的脑卒中治疗需 ...

Financial Performance - Revenue for the fiscal year 2023 increased to RMB 232.3 million, representing a year-on-year growth of 26.9%[2] - Gross profit rose to RMB 163.8 million, with a gross margin of 70.5%, up 2.6 percentage points from the previous year[2] - Pre-tax loss narrowed to RMB 102.9 million, a decrease of 48.9% compared to the previous year[2] - Basic and diluted loss per share improved to RMB (2.47) from RMB (5.24) year-on-year[3] - Total revenue from medical device sales for 2023 was RMB 232,344,000, an increase of 27% compared to RMB 183,032,000 in 2022[25] - Revenue from the mainland China market was RMB 231,273,000 in 2023, up from RMB 182,909,000 in 2022, reflecting a growth of 26%[50] - The company reported a pre-tax loss of RMB 102,920,000 for 2023, an improvement from a loss of RMB 201,249,000 in 2022, indicating a reduction of about 48.9%[61] - The basic and diluted loss per share for 2023 was RMB 2.47, compared to RMB 5.24 in 2022, reflecting a significant decrease in losses per share[77] Expenses and Cost Management - Sales and distribution expenses decreased by 8.4% to RMB 153.9 million, while R&D costs reduced by 19.4% to RMB 123.8 million[1] - Employee costs amounted to RMB 439 million, representing 35.5% of total costs, compared to RMB 519 million or 33.8% in the previous year[109] - The gross profit margin increased by 2.6 percentage points to 70.5%, with sales and distribution expenses and administrative expenses decreasing to 66.2% of revenue, down from 91.8% in 2022[112] - R&D expenses decreased from RMB 153.7 million for the year ended December 31, 2022, to RMB 123.8 million for the year ended December 31, 2023, primarily due to a reduction in the number of projects and R&D team size[158] Product Development and Innovation - Neurointerventional devices contributed 42.3% of total sales, with revenue from these products growing by 62.9% to RMB 98.2 million[2] - The company plans to launch at least five major neurointerventional devices in the next 24 months, including drug-coated balloons and stents[2] - Research and development costs amounted to RMB 123.8 million, aimed at supporting the diversification of neurointerventional devices, with at least five major products expected to launch in the next 24 months[113] - The core product, Captor® thrombectomy device, was the first in China to receive NMPA approval and has been upgraded to include various models for different vessel diameters and thrombus sizes[93] - The intracranial drug-eluting balloon catheter is in the NMPA registration phase after completing clinical trials, having received green channel approval[96] - The company has a total of 195 registered patents, including 87 invention patents, and 135 pending patent applications, indicating a strong focus on innovation[125] Market Expansion and Sales Channels - The company has obtained CE or FDA certification for several products and is expanding its sales channels in ten other countries[2] - The company has established a distribution network covering over 1,500 hospitals across all provinces in China, excluding Hong Kong, Macau, and Taiwan[101] - The company is evaluating opportunities for overseas marketing of its products, including potential registration applications in the United States[93] Financial Position and Assets - Total current assets decreased to RMB 1,005.4 million from RMB 1,132.0 million in the previous year[5] - The company’s net assets amounted to RMB 1,075.6 million, down from RMB 1,165.5 million in the previous year[5] - Cash and bank balances as of December 31, 2023, were RMB 622.2 million, a decrease of RMB 247.9 million from RMB 870.1 million as of December 31, 2022[139] - The net current assets as of December 31, 2023, were RMB 945.6 million, down from RMB 1,064.5 million as of December 31, 2022[162] Tax and Regulatory Matters - The company has been recognized as a "High-tech Enterprise" since November 2021, allowing it to enjoy a preferential tax rate of 15% for three years starting from 2021[34] - The company has been recognized as a key industry enterprise in the China (Shanghai) Free Trade Zone, benefiting from a preferential income tax rate of 15% for five years starting from 2020[58] - The company has a 200% super deduction rate for eligible R&D expenses for the fiscal year ending December 31, 2023, enhancing its tax efficiency[59] - The company has not been affected by the Pillar Two model rules introduced by the OECD, as it does not fall within the scope of these regulations[22] Corporate Governance and Compliance - The audit committee consists of three members, including two independent non-executive directors, ensuring compliance with the listing rules[200] - The company has confirmed adherence to the standard code of conduct during the reporting period[200] - The company has confirmed no non-compliance issues among senior management during the reporting period[200] - The company is committed to maintaining internal controls and risk management practices as discussed with the audit committee[200] Future Plans and Strategic Focus - The company plans to develop innovative medical devices in high-growth potential markets to establish a competitive product portfolio beyond its neuro-interventional business[152] - The company aims to enhance its manufacturing capabilities to ensure a reliable supply of products[104] - The company plans to enhance its brand recognition as a comprehensive provider of neurointerventional solutions and aims to accelerate the commercialization of its products[129] - The company has set a timeline for the completion of its core product R&D and marketing by December 31, 2025[195]

Financial Performance - Revenue for the six months ended June 30, 2023, increased by 42.9% to RMB 109,586 thousand compared to RMB 76,713 thousand in the same period last year[26] - Gross profit rose by 56.7% to RMB 79,718 thousand, with gross margin improving by 6.4 percentage points to 72.7%[26] - The company's pre-tax loss decreased by 18.4% to RMB (54,636) thousand compared to RMB (66,985) thousand in the same period last year[26] - Revenue for the first half of 2023 reached RMB 109.6 million, a year-on-year increase of 42.9%, driven by strong sales of acute ischemic stroke (AIS) thrombectomy devices, intracranial artery stenosis treatment devices, and innovative access devices[28] - Gross profit increased by RMB 28.9 million, with the gross margin rising to 72.7%, while the sales, distribution, and administrative expense ratio decreased from 96.8% to 65.2%, narrowing the pre-tax loss to RMB 54.6 million[29] - Revenue increased by 42.9% from RMB 76.7 million in the six months ended June 30, 2022, to RMB 109.6 million in the six months ended June 30, 2023, driven by growth in sales of AIS thrombectomy devices, intracranial artery stenosis treatment devices, and innovative access devices[63] - Gross profit rose to RMB 79.7 million in the six months ended June 30, 2023, from RMB 50.9 million in the same period in 2022, with gross margin improving from 66.3% to 72.7% due to increased production and improved manufacturing processes[65] - Net loss narrowed to RMB 54,338 thousand in H1 2023, a 18.7% improvement from RMB 66,815 thousand in H1 2022[185] - Basic and diluted loss per share improved to RMB 1.42 in H1 2023 from RMB 1.75 in H1 2022[185] Product Development and Pipeline - The company's core product, Captor™ thrombectomy device, has been upgraded with nine different models and is being evaluated for new indications and overseas market expansion[13] - The intracranial drug-eluting balloon (DEB) has completed clinical trials and submitted for NMPA registration, with green channel qualification obtained[15] - The company has obtained NMPA approval for its embolic coils, which are used in the treatment of hemorrhagic stroke[16] - The company's spring coil embolization assist stent has completed clinical trials and submitted for NMPA registration, also with green channel qualification[17] - The company's left atrial appendage occluder, a core product for stroke prevention, received NMPA approval and began sales in the second half of 2022[19] - The company has 21 medical devices approved by the NMPA and 2 approved by the FDA, with several advanced pipelines, including drug-eluting balloons and flow diverters, in late-stage development[29][30] - The company’s pipeline includes products for acute ischemic stroke treatment, ischemic stroke prevention, hemorrhagic stroke treatment, and interventional access, with a focus on expanding its product portfolio[31][43] Research and Development - R&D expenses for the reporting period amounted to RMB 69.9 million, focusing on advancing pipelines for stroke and pulmonary embolism treatment[29] - R&D costs increased to RMB 69.9 million in the six months ended June 30, 2023, from RMB 60.9 million in the same period in 2022, primarily due to higher raw material and consumable costs for trial production of pipeline products[67] - R&D expenses increased to RMB 69,850 thousand in H1 2023, up 14.7% from RMB 60,908 thousand in H1 2022[185] Sales and Distribution - The company has a broad sales network covering all provinces in China, excluding Hong Kong, Macau, and Taiwan[22] - The company’s sales network and hospital penetration strategy aim to enhance brand competitiveness in the Chinese neurointerventional market, leveraging the VBP and DRG/DIP payment reforms[28] - Sales and distribution expenses increased to RMB 41.7 million in the six months ended June 30, 2023, from RMB 36.0 million in the same period in 2022, driven by higher market development costs[86] Production and Operations - The company has three production bases in Shanghai and Nanjing, ensuring sufficient product supply[20] - The company’s production process optimization and cost-control measures have improved quality stability and operational efficiency[29] - As of June 30, 2023, the company’s contracted but not yet provided for plant and equipment amounted to RMB 9.11 million, compared to RMB 7.53 million at the end of 2022[40] Financial Position and Capital Expenditures - Cash and bank balances decreased to RMB 694.6 million as of June 30, 2023, from RMB 870.1 million as of December 31, 2022[70] - Capital expenditures totaled approximately RMB 47.2 million in the six months ended June 30, 2023, compared to RMB 23.8 million in the same period in 2022, mainly for the purchase of land use rights[90] - The company's net current assets stood at RMB 978.2 million as of June 30, 2023, down from RMB 1,064.5 million as of December 31, 2022[89] - The company's debt-to-equity ratio decreased to 3.9% as of June 30, 2023, from 4.3% as of December 31, 2022, with no outstanding borrowings as of June 30, 2023[88] Corporate Governance and Shareholder Information - The maximum number of H shares that can be granted under the 2021 H Share Incentive Plan is 3,000,000 H shares, representing approximately 9.5% of the company's H shares and 7.7% of the total issued share capital as of the report date[106] - As of January 1, 2023, and June 30, 2023, the total number of shares available for grant under the 2021 H Share Incentive Plan was 2,717,300 shares and 2,493,840 shares, respectively[106] - The company's global offering in 2021 raised a net amount of approximately HKD 1,014.8 million[109] - The company had 453 full-time employees as of June 30, 2023[116] - The 2021 H Share Incentive Plan allows for two types of awards: (i) three-year awards, which should be granted by December 31, 2024, and vest at the end of the third full fiscal year after grant (for up to 2,700,000 H shares), and (ii) one-year awards, which should vest by June 30 of the year following the grant year (with up to 100,000 H shares in 2022 and up to 300,000 H shares annually thereafter)[121] - The company has no significant contingent liabilities as of June 30, 2023[114] - The company faces foreign exchange risk due to bank cash denominated in USD and HKD, but currently has no foreign exchange hedging policy[115] - The 2021 H Share Incentive Plan is effective for ten years from November 1, 2021, and will remain in effect for any unvested awards granted before its expiration[120] - The company's directors and senior management's compensation policy is determined based on their responsibilities and market conditions, with discretionary and performance bonuses linked to the group's overall performance and individual performance[116] - The company's H shares were first listed on the Main Board of the Hong Kong Stock Exchange on August 20, 2021[109] - The company allocated HKD 459.7 million for the R&D, production, and marketing of its core products, with HKD 223.4 million utilized as of June 30, 2023, leaving a balance of HKD 236.3 million[129] - HKD 404.9 million was planned for the R&D and product registration of other pipeline products, with HKD 185.7 million utilized as of June 30, 2023, and a remaining balance of HKD 219.2 million[129] - HKD 48.7 million was fully utilized for enhancing R&D capabilities and expanding the product portfolio through internal research as of June 30, 2023[129] - HKD 101.5 million was allocated for working capital and general corporate purposes, fully utilized as of June 30, 2023[129] - The total funds raised from the IPO amounted to HKD 1,014.8 million, with HKD 559.3 million utilized as of June 30, 2023, and a remaining balance of HKD 455.5 million[129] - The company granted awards under the 2021 H Share Incentive Plan, with a fair value of approximately RMB 2.96 million, and 100% of the awards will vest by December 31, 2025, subject to performance conditions[150] - The company's independent auditor, Ernst & Young, reviewed the interim financial information for the six months ended June 30, 2023, in accordance with Hong Kong Standard on Review Engagements 2410[135] - The company's directors and senior management held significant equity interests, with Wang Guohui holding 8.21% of non-listed shares and 20.99% of H shares as of June 30, 2023[144] - The company did not purchase, sell, or redeem any of its listed securities during the six months ended June 30, 2023[130] - The company adopted the Standard Code as the code of conduct for directors, supervisors, and senior management regarding the trading of the company's securities[131] - The company does not recommend paying an interim dividend for the six months ended June 30, 2023 (no interim dividend was paid for the six months ended June 30, 2022)[153] - The company's Board of Directors and senior management have complied with the standard code of securities transactions during the six months ended June 30, 2023[154] - Wang Guohui serves as both the Chairman and CEO of the company, deviating from the corporate governance code, but the Board believes this structure enhances leadership and strategic planning efficiency[156] - The Audit Committee and management confirm that the interim financial results for the six months ended June 30, 2023 comply with relevant accounting standards and regulations[157] - Feng Xiangqian was appointed as the Chairman of the Nomination Committee, effective March 20, 2023[159] - Wang Guohui directly holds 1,915,690 non-listed shares and 1,915,690 H shares, with additional interests through related entities[169] - Zhang Yanxia holds 3,188,110 non-listed shares (8.21%) and 8,152,618 H shares (20.99%) through spousal interests[171] - Shanghai Zandaqian Enterprise Management Consulting Center holds 496,183 non-listed shares (1.28%) and 4,777,225 H shares (12.30%) through controlled corporation interests[171] - Ningbo Meishan Bonded Port Area Xinwei Investment Management Partnership holds 776,237 non-listed shares (2.00%) and 1,459,703 H shares (3.76%) as beneficial owner[171] - Ningbo Meishan Bonded Port Area Kaiyuan Investment Management Partnership holds 1,277,192 H shares (3.29%) as beneficial owner[171] - Shanghai Weijun Enterprise Management Consulting Partnership holds 2,800,000 H-shares, representing 7.21% of the total issued shares[174] - Chai Yanpeng holds 1,566,488 non-listed shares, representing 4.03% of the total issued shares[174] - Ningbo Tongchuang Suwei Investment Partnership holds 869,330 non-listed shares, representing 2.24% of the total issued shares[174] - SDIC Chuanghe National Emerging Industry Venture Capital Fund holds 906,220 non-listed shares, representing 2.33% of the total issued shares[174] - Temasek Life Sciences Private Limited holds 1,627,907 H-shares, representing 4.19% of the total issued shares[174] - LYFE Columbia River Limited holds 152,599 non-listed shares, representing 0.39% of the total issued shares[174] - LYFE Ohio River Limited holds 49,147 non-listed shares, representing 0.13% of the total issued shares[174] - Raritan River Limited holds 65,116 non-listed shares, representing 0.17% of the total issued shares[174] - LYFE Capital Fund III (Dragon), L.P. holds 201,746 non-listed shares, representing 0.52% of the total issued shares[174] - LYFE Capital Management Limited holds 13.64% of H-shares and 0.69% of non-listed shares[198] - LYFE Columbia River Limited directly holds 2,899,373 H-shares and 152,599 non-listed shares[199] - LYFE Ohio River Limited directly holds 933,784 H-shares and 49,147 non-listed shares[199] - Raritan River Limited directly holds 1,237,210 H-shares and 65,116 non-listed shares[199] - LYFE Capital Fund III (Dragon), L.P. directly holds 227,300 H-shares[199] Audit and Compliance - The interim financial report for 2023 has been reviewed and no material misstatements were found according to International Accounting Standard 34[183] - The company's independent auditor, Ernst & Young, reviewed the interim financial information for the six months ended June 30, 2023, in accordance with Hong Kong Standard on Review Engagements 2410[135] - The Audit Committee and management confirm that the interim financial results for the six months ended June 30, 2023 comply with relevant accounting standards and regulations[157] Strategic Plans and Market Expansion - The company plans to expand its brand as a comprehensive neurointerventional device provider, improve manufacturing capabilities, and develop innovative medical devices in high-growth potential markets[62] - Overseas revenue increased following the approval of multiple products by local regulatory authorities, supported by a broad sales network covering all provinces in mainland China, excluding Hong Kong, Macau, and Taiwan[28]

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 109.586 million, representing a 42.9% increase compared to RMB 76.713 million for the same period in 2022[18]. - Gross profit increased to RMB 79.718 million, up 56.7% from RMB 50.865 million year-on-year, with a gross margin of 72.7%, an increase of 6.4 percentage points[18]. - The pre-tax loss narrowed to RMB 54.636 million, a decrease of 18.4% from RMB 66.985 million in the previous year[18]. - For the first half of 2023, the company recorded revenue of RMB 1,096 million, representing a year-on-year growth of 42.9%[33]. - The revenue increase was primarily driven by the continued growth in sales of acute ischemic stroke (AIS) thrombectomy devices and intracranial artery stenosis treatment devices[33]. - For the six months ended June 30, 2023, the company reported a loss attributable to ordinary shareholders of RMB 54,338 thousand, compared to a loss of RMB 66,815 thousand for the same period in 2022, representing a reduction in loss of approximately 18.7%[50]. - The gross profit for the six months ended June 30, 2023, increased by RMB 28.9 million, with a gross margin of 72.7%, compared to a gross margin of 96.8% in the previous period, indicating improved operational efficiency[55]. - Revenue from the sale of medical devices reached RMB 109,586 thousand for the six months ended June 30, 2023, up from RMB 76,713 thousand in the same period of 2022, reflecting an increase of approximately 43%[62]. Expenses and Cost Management - The company achieved a significant reduction in sales and distribution expenses and administrative expenses ratio from 96.8% to 65.2%[15]. - Research and development costs increased to RMB 69.850 million from RMB 60.908 million in the previous year[20]. - The cost of sales increased from RMB 25.8 million for the six months ended June 30, 2022, to RMB 29.9 million for the same period in 2023, consistent with revenue growth[91]. - Administrative expenses decreased from RMB 38.3 million for the six months ended June 30, 2022, to RMB 29.8 million for the same period in 2023, primarily due to a reduction in professional service fees[94]. - Sales and distribution expenses increased from RMB 36.0 million for the six months ended June 30, 2022, to RMB 41.7 million for the six months ended June 30, 2023, primarily due to increased market development costs[121]. - Employee costs for the six months ended June 30, 2023, were RMB 23.7 million, representing 33.9% of total costs, compared to RMB 24.0 million or 39.4% for the same period in 2022[144]. - The total costs for raw materials and consumables increased to RMB 18.2 million, accounting for 26.0% of total costs, compared to RMB 9.1 million or 14.9% in the previous year[144]. Assets and Liabilities - The total non-current assets as of June 30, 2023, amounted to RMB 215.892 million, an increase from RMB 180.537 million at the end of 2022[21]. - Cash and bank balances decreased to RMB 694.552 million from RMB 870.122 million at the end of 2022[21]. - Total current liabilities decreased from RMB 67,506 thousand as of December 31, 2022, to RMB 55,488 thousand as of June 30, 2023[38]. - The net value of current assets was RMB 978,215 thousand as of June 30, 2023, down from RMB 1,064,516 thousand as of December 31, 2022[38]. - Non-current liabilities totaled RMB 76,582 thousand as of June 30, 2023, a decrease from RMB 79,576 thousand as of December 31, 2022[38]. - The total equity attributable to owners of the parent company was RMB 1,117,525 thousand as of June 30, 2023, compared to RMB 1,165,477 thousand as of December 31, 2022[38]. - The company's debt was reduced to zero as of June 30, 2023, compared to RMB 50 million on December 31, 2022, resulting in a decrease in the debt-to-equity ratio from 4.3% to 3.9%[172]. Product Development and Approvals - The company has obtained NMPA approval for its core product, the left atrial appendage occluder, and began sales in the second half of 2022[5]. - As of the announcement date, the company has a total of 21 medical device products approved by NMPA and two products approved by FDA[34]. - The company has submitted registration applications for its intracranial drug-eluting balloon and embolization spring coil, which have received NMPA review green channel qualifications[80][108]. - The company is evaluating opportunities to expand the indications for its core product, the Captor™ thrombectomy device, and is considering overseas marketing opportunities in the US and Europe[59]. - Clinical trial patient recruitment for the flow diversion device has been completed, indicating progress in product development[179]. - The company has obtained priority approval qualifications for several products through its existing R&D platform, enhancing its competitive product portfolio[169]. Corporate Governance and Strategy - The company aims to enhance its brand competitiveness in the Chinese neurointerventional market through an extensive sales network covering all provinces outside Hong Kong, Macau, and Taiwan[3]. - The company aims to enhance its brand recognition as a comprehensive provider of neurointerventional solutions and expand the commercialization of its products[114]. - The company plans to apply for listing on the Shanghai Stock Exchange's Sci-Tech Innovation Board to further its growth strategy[114]. - The board consists of two non-executive directors, three independent non-executive directors, and three executive directors, ensuring a high level of independence[171]. - The company is committed to continuous review and monitoring of its corporate governance practices to enhance management standards and protect shareholder interests[185]. - The company has adopted the corporate governance code as its own to regulate governance practices, ensuring compliance with all relevant provisions[185]. Cash Flow and Future Outlook - The management expects to generate more cash from operating activities through increased sales of existing commercialized products and the launch of new products as the business develops and expands[147]. - The company did not recommend the payment of an interim dividend for the six months ended June 30, 2023[10]. - The company has no plans to declare dividends for the six months ended June 30, 2023, consistent with the previous year[68]. - The group did not engage in any significant acquisitions or disposals of subsidiaries, associates, or joint ventures as of June 30, 2023[125]. - There were no significant investments or capital asset acquisition plans authorized as of June 30, 2023[127].

Financial Performance - The company reported a revenue of RMB 183.0 million for the year ended December 31, 2022, representing a year-on-year growth of 103.2%[8] - Gross profit for the same period was RMB 124.3 million, compared to RMB 54.9 million in 2021[7] - The company incurred a pre-tax loss of RMB 201.2 million, slightly increasing from RMB 197.9 million in the previous year[7] - Revenue from thrombectomy and vascular stenosis treatment devices reached RMB 142.0 million, an increase of 57.7% year-on-year, while hemorrhagic, preventive, and access devices generated revenue of RMB 41.0 million[14] - Revenue increased by 103.2% from RMB 90.1 million in 2021 to RMB 183.0 million in 2022, driven by growth in ischemic stroke retrieval devices and intracranial artery stenosis treatment devices, which generated RMB 142.0 million, a 57.7% increase year-on-year[42] - Gross profit rose from RMB 55.0 million in 2021 to RMB 124.3 million in 2022, with gross margin improving from 61.0% to 67.9% due to increased production and mature manufacturing processes[44] - Other income and gains increased from RMB 18.3 million in 2021 to RMB 35.3 million in 2022, attributed to increased government subsidies, bank interest income, and foreign exchange gains[45] Research and Development - Research and development expenses reached approximately RMB 153.7 million, with seven new products approved by the National Medical Products Administration (NMPA) during the reporting period[9] - R&D expenses amounted to RMB 153.7 million, reflecting a year-on-year increase of 101.4% due to rapid progress in clinical trials of new products[14] - The company has initiated clinical trials for several innovative products, including cryoablation devices, endovascular robotic systems, and venous closure devices[15] - The intracranial drug-eluting balloon catheter has completed clinical trials and received NMPA registration application approval, qualifying for the NMPA green channel[27] - The company holds 100 registered patents, including 27 invention patents, 64 utility model patents, and 9 design patents, with an additional 214 pending patent applications[32] - The company has nearly 20 years of experience in the research and commercialization of medical devices[72] - The company is actively involved in the development and commercialization of drug-eluting stents (DES) and renal sympathetic denervation devices[76] Market Strategy and Growth - The company aims to enhance operational efficiency and cost structure to improve profit margins and cash flow[9] - Future growth is expected to be driven by continued focus on core neurointerventional medical devices and development of innovative pipelines in other therapeutic areas[9] - The company plans to leverage its R&D capabilities and sales channels for broader market penetration domestically and internationally[9] - The company is evaluating opportunities for expanding the indications and overseas marketing of the Captor device in the US and Europe[25] - The company aims to enhance its brand recognition as a comprehensive provider of neurointerventional devices and expand sales of commercialized products[40] - The company is expanding its market presence through strategic partnerships and investments in innovative medical technologies[80] - The company is expanding its market presence, planning to enter three new provinces in China by the end of 2023, which is expected to contribute an additional 10% to revenue[88] - A strategic acquisition of a smaller competitor is in progress, which is anticipated to enhance the company's market share by 5%[88] Corporate Governance - The company has adopted a corporate governance code to enhance management standards and protect shareholder interests[106] - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a high level of independence[112] - The company has established effective mechanisms to support an independent board and independent viewpoints[109] - The company has a strategy to enhance training for new employees to better understand corporate culture and policies[103] - The company has a commitment to maintaining high standards of corporate governance and will continue to review its practices[108] - The company has established an audit committee, a remuneration committee, and a nomination committee to oversee its governance practices[126] - The board of directors is collectively responsible for guiding and supervising the company's affairs, delegating daily management to senior management[121] Environmental, Social, and Governance (ESG) - The report covers the company's performance in environmental, social, and governance (ESG) aspects for the year 2022, from January 1 to December 31[182] - The company emphasizes the importance of stakeholder communication for sustainable development, engaging with shareholders, customers, employees, suppliers, and the community[188] - Key performance indicators in the ESG report are aligned with the Hong Kong Stock Exchange guidelines, ensuring transparency and consistency[181] - The company is committed to integrating sustainable development principles into its daily operations and overall strategic direction[186] - The company has established a materiality matrix to assess the importance of various environmental and social issues to stakeholders and its operations[191] - Total emissions of waste gases in 2022 amounted to approximately 31.0 kg, with a density of 16.9 kg per RMB 100 million in revenue, a 12.0% decrease compared to 2021[196] Employee and Management - As of December 31, 2022, the company had 497 full-time employees, with competitive salary and stock incentive plans in place to enhance employee retention[63] - The management team includes professionals with extensive backgrounds in quality systems, regulatory management, and clinical trials[75][76] - The management team has a strong educational background, with degrees from prestigious institutions such as Tsinghua University and Shanghai University[75][77] - The management team emphasized a focus on sustainability, with plans to reduce operational costs by 15% through eco-friendly practices[88] - The company ensures that all directors participate in continuous professional development to enhance their knowledge and skills[125] Financial Position - Non-current assets totaled RMB 180.5 million, while current assets were RMB 1,132.0 million as of December 31, 2022[7] - The total equity amounted to RMB 1,165.5 million, down from RMB 1,372.6 million in 2021[7] - The total borrowings amounted to RMB 5 million as of December 31, 2022, with a debt-to-equity ratio of 4.3%[53] - As of December 31, 2022, the company's cash and bank balance was RMB 870.1 million, down from RMB 1,217.7 million as of December 31, 2021, representing a decrease of approximately 28.5%[54] - The company's net current assets as of December 31, 2022, were RMB 1,064.5 million, compared to RMB 1,276.9 million as of December 31, 2021, indicating a decline of about 16.6%[54] Future Outlook - The company provided a positive outlook for the next fiscal year, projecting a revenue growth of 25% and aiming to reach 1.875 billion RMB[88] - New product development is underway, with two innovative medical devices expected to launch in Q3 2023, targeting a market size of 500 million RMB[88] - The company aims to become a leader in the neuro-interventional medical device market in China[103] - The long-term business model focuses on continuously launching innovative medical devices to redefine care standards and improve patient outcomes[102]

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。 Shanghai HeartCare Medical Technology Corporation Limited 上 海 心 瑋 醫 療 科 技 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6609） 截至2022年12月31日止年度 全年業績公告 財務概要 截至2022年 截至2021年 12月31日 12月31日 止年度 止年度 同比變動 人民幣千元 人民幣千元 收益 183,032 90,089 103.2% 毛利 124,333 54,950 126.3% 毛利率 67.9% 61.0% 6.9個百分點 研發成本 153,693 76,306 101.4% ...

Financial Performance - Revenue for the first half of 2022 reached RMB 76.7 million, representing a year-on-year increase of 154.6%[11] - Gross profit for the same period was RMB 50.9 million, with a gross margin of 66.3%, up 3.1 percentage points from the previous year[11] - The pre-tax loss for the first half of 2022 was RMB 67.0 million, a decrease of 28.5% compared to the previous year[11] - Revenue increased by 154.6% from RMB 30.1 million to RMB 76.7 million for the six months ended June 30, 2022, primarily driven by sales growth of ischemic stroke thrombectomy devices and intracranial artery stenosis treatment devices[34] - Gross profit rose from RMB 19.1 million to RMB 50.9 million, with the gross margin improving from 63.2% to 66.3% due to increased production and maturing production processes[36] - The company reported a loss before tax of RMB 66,985 thousand, an improvement from a loss of RMB 93,671 thousand in the prior year[98] - The group reported a pre-tax loss of RMB 66,815,000 for the six months ended June 30, 2022, compared to a loss of RMB 91,702,000 for the same period in 2021, representing a 27% improvement[138] Research and Development - Research and development expenses amounted to RMB 60.9 million, an increase of 88.0% year-on-year[11] - R&D expenses increased from RMB 32.4 million to RMB 60.9 million, mainly due to costs associated with advancing the R&D pipeline[38] - Research and development costs increased to RMB 60,908,000 in 2022 from RMB 32,392,000 in 2021, reflecting an increase of 88%[138] - The company is developing a comprehensive neuro-interventional product portfolio, including treatments for acute ischemic stroke and neurovascular stenosis[14] - The intracranial drug-eluting balloon catheter has completed clinical trials and is preparing for NMPA registration, having received green channel qualification[24] - The company has invested HKD 33.2 million in enhancing R&D capabilities and expanding its product portfolio, with a remaining balance of HKD 15.5 million from the planned HKD 48.7 million[60] Product Development and Approval - The company received NMPA approval for 6 new products in the first half of 2022, bringing the total to 15 approved neuro-interventional devices[13] - The company has obtained NMPA approval for various ischemic stroke treatment devices, including distal access catheters and suction devices, covering both stenting and suction thrombectomy procedures[23] - The left atrial appendage occluder, aimed at preventing stroke in non-valvular atrial fibrillation patients, is expected to begin sales in the second half of 2022 after receiving NMPA approval[26] - Captor™ thrombectomy device is the first multi-point contrast thrombectomy stent approved by NMPA in China, with upgrades offering nine product models for different vessel diameters and thrombus sizes[22] Market Expansion and Strategy - The company aims to expand its market presence by launching new products in the second half of 2022 to meet the demand for primary healthcare[13] - The company aims to enhance brand awareness as a comprehensive provider of neurointerventional solutions and accelerate the commercialization of its pipeline products[33] - The company plans to develop a complete set of innovative medical devices in the cardiac intervention market, creating a competitive second business unit[33] - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share within the next two years[166] - A strategic acquisition of a local competitor is expected to enhance the company's product portfolio and increase market penetration[166] Financial Position and Cash Flow - As of June 30, 2022, cash and bank balances were RMB 997.0 million, a decrease of RMB 220.7 million from RMB 1,217.7 million as of December 31, 2021[52] - The net cash flow from operating activities for the six months ended June 30, 2022, was RMB (142,233) thousand, compared to RMB (70,542) thousand in the same period of 2021[109] - The company reported a net cash outflow from financing activities of RMB 27,792,000 for the first half of 2022, compared to a net outflow of RMB 3,342,000 in the same period of 2021[122] - The total cash and cash equivalents at the end of the reporting period were RMB 996,952,000, compared to RMB 129,232,000 at the end of the same period in 2021, showing a substantial increase[122] Shareholder Structure and Governance - The company has a significant shareholder structure with multiple entities holding substantial stakes, including Temasek Holdings with 4.55% in H shares[74] - The ownership distribution indicates a strong presence of institutional investors, which may influence corporate governance and strategic decisions[74] - The company is actively engaging with major investment firms, including Fullerton Management and LYFE Capital, to bolster its financial position[79] - The company has maintained a high standard of corporate governance, with a diverse and experienced board composition[90] Corporate Actions and Compliance - The board of directors did not recommend the payment of an interim dividend for the six months ended June 30, 2022[64] - The independent auditor, Ernst & Young, conducted a review of the interim financial data and found no significant issues[96] - The company has adopted a code of conduct for trading its securities, ensuring compliance by all directors and senior management during the reporting period[89] - There were changes in the board of directors, with Mr. Wei Jiawei appointed as an executive director on June 10, 2022, and several resignations effective August 31, 2022[84][86] Future Outlook - The company provided a future outlook, projecting a revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion[166] - The company aims to reduce operational costs by 10% through efficiency improvements and automation[166] - A new partnership with a leading healthcare provider is expected to enhance service delivery and customer engagement[166]