Financial Performance - Revenue for 2021 reached RMB 90.1 million, a significant increase of 517% compared to RMB 14.6 million in 2020[9][11] - Gross profit for 2021 was RMB 54.95 million, up from RMB 7.087 million in 2020[9] - The company reported a net loss of RMB 197.906 million in 2021, compared to a net loss of RMB 216.183 million in 2020[9] - Total non-current assets increased to RMB 172.324 million in 2021 from RMB 111.849 million in 2020[9] - Total current assets rose to RMB 1.332 billion in 2021 from RMB 661.782 million in 2020[9] - Total equity increased to RMB 1.373 billion in 2021 from RMB 691.035 million in 2020[9] - Gross margin improved from 49% in 2020 to 61% in 2021 due to increased production and corresponding economies of scale[41] - R&D costs increased from RMB 51.1 million in 2020 to RMB 76.3 million in 2021, primarily due to increased R&D expenses for in-development medical devices[45] - Administrative expenses decreased to RMB 83.9 million in 2021 from RMB 141.9 million in 2020, primarily due to reduced share-based compensation expenses[47] - Sales and distribution expenses rose to RMB 51.1 million in 2021, a 257.3% increase from RMB 14.3 million in 2020, driven by sales team expansion[48] - Cash and bank balances surged 92.6% to RMB 1,217.7 million in 2021, primarily due to proceeds from the global offering[53] - Capital expenditures totaled RMB 54.5 million in 2021, used for purchasing equipment, machinery, and software[53] - Employee benefits expenses decreased to RMB 114.3 million in 2021 from RMB 157.9 million in 2020, mainly due to reduced share-based compensation[60] - The company allocated RMB 59.0 million of the global offering proceeds for core product R&D, production, and marketing, with RMB 400.7 million remaining[57] - The company's audit fees for the fiscal year ending December 31, 2021, amounted to approximately RMB 8.58 million, with non-audit service fees for internal control review totaling RMB 0.45 million[167] - Total fees paid or payable to the auditor for audit and non-audit services for the fiscal year ending December 31, 2021, were RMB 9.03 million, including RMB 3.9 million for annual audit services and RMB 4.68 million for IPO services[168] Market Expansion and Sales - The company's full suite of thrombectomy devices has achieved market access in almost all provinces in China, covering approximately 1,400 hospitals across 31 provinces[11] - The company established a sales network including over 100 distributors and more than 100 sales personnel[11] - Revenue from commercialized neurointerventional devices reached RMB 90.1 million in 2021, supported by a sales network covering 31 provinces[17] - The company's sales and marketing team consists of over 100 employees, with a distribution network covering more than 1,400 hospitals across 31 provinces in China[36] - The company's revenue increased by 517% from RMB 14.6 million in 2020 to RMB 90.1 million in 2021, driven by sales of ischemic stroke thrombectomy devices and intracranial artery stenosis treatment devices[39] Product Development and Innovation - The company's neurovascular stenosis treatment product portfolio, approved in 2021, contributed to the revenue growth[11] - The company has obtained NMPA approval for 11 neurointerventional devices, covering three major surgical procedures and neurointerventional access devices[12] - Two products have received FDA 510K certification, marking the company's entry into the international market[12] - The company has approximately 20 emerging product pipelines in development, including left atrial appendage occluders and electrophysiology devices[13] - The company has 3 neurointerventional products in clinical trials and 4 under registration review[18] - Core product Captor™ thrombectomy device, the first multi-point imaging thrombectomy stent approved by NMPA in China, has been upgraded with 9 different models for various vessel diameters and thrombus sizes[25] - The company plans to expand Captor's indications and explore overseas marketing opportunities, potentially applying for registration in the US and Europe[25] - The company expects to obtain NMPA approval for its left atrial appendage occluder in Q2 2022 and begin sales in the second half of 2022[30] - The company has developed a comprehensive neurointerventional product portfolio, including 11 NMPA-approved products and a broad pipeline[19] - The company is advancing multiple innovative medical device pipelines in lung intervention and computer-assisted technology fields[13] - The company plans to expand its product portfolio in the cardiac intervention field, including robotic-assisted coronary intervention[13] Corporate Governance and Leadership - The company successfully listed on the Hong Kong Stock Exchange on August 20, 2021 (Stock Code: 6609)[9][11] - The company has adopted the Corporate Governance Code of the Hong Kong Stock Exchange (HKEX) and will apply the new version effective from January 1, 2022, for the fiscal year ending December 31, 2022[114] - The Chairman and CEO roles are combined, held by Mr. Wang Guohui, which deviates from the Corporate Governance Code but is deemed beneficial for leadership consistency and strategic efficiency[116] - The Board of Directors consists of 2 executive directors, 3 non-executive directors, and 3 independent non-executive directors, ensuring a high level of independence[122] - The company held 2 Audit Committee meetings and 2 Remuneration Committee meetings from the listing date to December 31, 2021[115] - The Chairman intends to hold at least one annual meeting with independent non-executive directors without the presence of other directors, as per the Corporate Governance Code[120] - All directors and supervisors confirmed compliance with the Model Code for Securities Transactions from the listing date to December 31, 2021[121] - The company has a Nomination Committee that evaluates the skills, knowledge, and experience required for the Board and recommends suitable candidates[127] - The company’s Board Diversity Policy is considered when evaluating and determining director candidates[130] - The company has received annual written confirmations of independence from all independent non-executive directors[125] - The company’s directors are elected for a term of three years and can be re-elected or removed by ordinary resolution[127] - The company has established three board committees: Audit Committee, Remuneration Committee, and Nomination Committee, each with defined responsibilities and sufficient resources to fulfill their duties[131][137] - The Audit Committee, chaired by Mr. Gong Ping, consists of one non-executive director and two independent non-executive directors, and held 2 meetings during the reporting period[138][139] - The Remuneration Committee, chaired by Mr. Guo Shaomu, consists of one executive director and two independent non-executive directors, and held 2 meetings to review the 2021 H-share incentive plan and related grant schemes[141][143] - The Nomination Committee, chaired by Mr. Wang, consists of one executive director and two independent non-executive directors, and did not hold any meetings during the reporting period[145][146] - The company has adopted a Board Diversity Policy to enhance the effectiveness of the Board and maintain high standards of corporate governance, considering factors such as gender, age, culture, educational background, and professional experience[149] - The company has arranged appropriate insurance coverage for directors, supervisors, and senior management to protect them against legal actions arising from company affairs, with the coverage reviewed annually[133] - All directors are required to participate in continuous professional development to update their knowledge and skills, and are encouraged to attend relevant training courses at the company's expense[135] - The company's senior management, including 2 directors, had a total of 5 members with annual remuneration ranging from RMB 1 million to RMB 30 million in 2021[144] - The Audit Committee reviewed the company's 2021 interim report and annual audit plan during the reporting period[140] - The Remuneration Committee is responsible for recommending the remuneration policy and structure for all directors and senior management, and determining their specific remuneration packages[141] - The company aims to achieve a target of 20% female representation on the board by actively seeking qualified female candidates[150] - The company held 6 board meetings, 2 audit committee meetings, and 2 remuneration committee meetings from the listing date to December 31, 2021[158] - All directors attended all 6 board meetings during the period from the listing date to December 31, 2021[160] - The company held one extraordinary general meeting on November 1, 2021, attended by Mr. Wang Guohui and Mr. Ding Kui[162] - The board is responsible for ensuring the timely publication of the company's financial statements and preparing them on a going concern basis[166] ESG and Sustainability - The company has integrated sustainable development concepts into its daily operations, aligning its overall strategic direction with sustainable development goals[192] - The company aims to become a leader in the domestic neurointervention market by providing a one-stop solution for stroke treatment and prevention[195] - In 2021, the company received multiple honors, including being recognized as a high-tech enterprise and a "Specialized, Refined, and Innovative" small and medium-sized enterprise in Shanghai[196] - The company actively communicates with stakeholders, including shareholders, customers, employees, suppliers, government and regulatory agencies, and the community, to understand their expectations and opinions on sustainable development[197] - High importance issues identified for the company's ESG (Environmental, Social, and Governance) reporting[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] - Medium importance issues identified for the company's ESG reporting[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] - Low importance issues identified for the company's ESG reporting[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] - Importance matrix established based on stakeholder input and business significance assessment[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] Risk Management and Internal Controls - The company's internal audit department is responsible for identifying and assessing major risks across operations and monitoring the correction of internal control deficiencies[185] - The internal audit department reviewed the effectiveness of internal controls related to major business processes, identified gaps and improvement opportunities, and recommended corrective actions. No significant internal control system deficiencies were identified[186] - The company has established a monitoring system to accept complaints and reports regarding violations by employees and external distributors and suppliers[189] - The Board of Directors reviewed the risk management and internal control systems for the year ended December 31, 2021, and found them to be effective and adequate[190] - The company has implemented anti-corruption and anti-bribery compliance training for directors, senior management, and sales employees to enhance their understanding and compliance with applicable laws and regulations[186] Leadership and Key Personnel - The company's executive director, Mr. Wang Guohui, has over 20 years of experience in medical device R&D and commercialization, previously holding key roles at leading medical technology companies[72][73] - The company's executive director, Ms. Zhang Kun, has over 20 years of experience in medical device R&D and commercialization, with a focus on clinical trials and cardiac intervention business[75][76] - The company's non-executive director, Mr. Ding Kui, has over 15 years of experience in finance and the medical industry, currently serving as Vice President and Board Secretary of Shanghai Kinetic Medical Co., Ltd[78] - Chen Gang joined the company as a director in June 2020 and was re-designated as a non-executive director in November 2020, providing strategic advice on operations and management[81] - Chen Gang has over 14 years of experience in the financial industry, including roles at L.E.K. Consulting and Vivo Capital, focusing on business strategy and M&A for healthcare and life sciences clients[81] - Chen Gang has held various positions in companies such as Shanghai Alland Biotech, CoreCatch Medical, and Sinomed, contributing to international business development and board roles[82] - Chen Gang currently serves as a director for multiple external companies, including Beijing Anzhiyin Biotech and Shanghai GenScript Biotech, focusing on biopharmaceutical CDMO services[83] - Ouyang Xiangyu joined the company as a director in June 2020 and was re-designated as a non-executive director in November 2020, providing strategic advice on operations and management[84] - Ouyang Xiangyu has extensive experience in the high-tech and financial industries, including roles at Legend Capital and founding Sharlyn Capital in 2018[85] - Guo Shaomu has over 13 years of experience in Hong Kong investment banking, including roles at Salomon Smith Barney, HSBC Markets, J.P. Morgan, and Morgan Stanley, focusing on financial services and real estate markets[89] - Guo Shaomu currently serves as an independent non-executive director for several listed companies, including Yida China Holdings and Fantasia Holdings Group[90] - Feng Xiangqian joined the company as an independent non-executive director in November 2020, providing independent opinions on operations and management[93] - Feng Xiangqian has over 14 years of experience in the financial industry, including roles at Caitong Securities, Donghai Securities, and Shenzhen Stock Exchange, focusing on IPO and investment banking[93] - Gong Ping, aged 35, has been serving as an independent non-executive director since January 11, 2021, providing independent opinions on the company's operations and management[94] - Zhou Baolei, aged 36, joined the company in September 2019 and was appointed as a supervisor on November 23, 2020, responsible for overseeing the company's operations[96] - Mei Jianghua, aged 44, joined the company in September 2019 and was appointed as a supervisor on November 23, 2020, responsible for overseeing the company's operations[96] - Xing Tingyu, aged 36, joined the company in August 2019 and was appointed as an employee supervisor on November 23, 2020, responsible for representing employees in overseeing the company's operations[98] - Wang Guohui, aged 44, has been serving as the CEO since the company's establishment in June 2016 and was appointed as the Chairman on November 23, 2020[100] - Li Zhigang, aged 60, has been serving as the Vice President since November 2020, responsible for the company's R&D management[101] - Wei Jiawei, aged 44, joined the company in September 2020 and was appointed as Vice President on November 23, 2020, responsible for the company's sales management[104] - Zhang Han, aged 35, joined the company in November 2020 and was appointed as CFO on November 23, 2020, responsible for the company's strategic development and financial management[107] Shareholder Communication and Investor Relations - The company has established multiple communication channels with shareholders, investors, and other stakeholders, including the publication of interim and annual reports, shareholder meetings, and online resources[181] - The company has no immediate plans to declare or pay any dividends, as it intends to retain all future earnings for business operations and expansion[182] Strategic Goals and Future Plans - The company aims to enhance its brand competitiveness and market share in the neurointerventional market in the coming years[14] - The company aims to become a leader in China's neurointerventional medical device market and develop a competitive product portfolio in the cardiac intervention market[38] - The company plans to expand manufacturing facilities in the Lingang New Area to meet growing product demand[34] - A new production facility in Shanghai's Lingang area has obtained medical device production licenses to ensure stable supply[17] Intellectual Property and Patents - The company has 50 registered patents in China, including 13 invention patents, 36 utility model patents, and 1 design patent, with 124 pending patent applications[32] Share Incentive Plans and Equity Transactions - The company implemented the 2021 H Share Incentive Plan, with a maximum of 750,000 H shares available for acquisition by the trustee[62] - The 2021 H Share Incentive Plan will be funded by the company's internal resources and not from the global offering proceeds[64] - The company purchased a total of 274,450 shares under the 2021 H-share incentive plan at an average price of HKD 94 per share, with a total cost of approximately HKD 25.8 million (excluding brokerage commissions and other expenses)[65] - Under the 2021 H-share incentive plan, the company granted 386,700 shares to employees in January 2022[68] - The company's shares were purchased under the 2021 H-share incentive plan on the Hong Kong Stock Exchange for a total consideration of RMB 14.813 million (excluding expenses)[67] Acquisitions and Investments - The company acquired a 36% equity stake in Shanghai Yuban Medical Technology Co., Ltd. for a total consideration of RMB 34.8 million, with RMB 4.8 million paid in March 2022[67] - The company's subsidiary, Shanghai Weiqi Medical Device Co., Ltd., entered into an agreement to acquire equity and inject capital into Shanghai Yuban Medical Technology Co., Ltd[67] - The company has not authorized any significant investment or capital asset acquisition plans as of the report date[66] Foreign Exchange Risk - The company faces foreign exchange risk due to bank cash denominated in USD and HKD, with no current foreign currency hedging policy in place[69]

上海心瑋醫療科技股份有限公司 Shanghai HeartCare Medical Technology Corporation Limited (A joint stock company incorporated in the People's Republic of China with limited liability) (於中華人民共和國註冊成立的股份有限公司) Stock Code 股份代號：6609 2021 INTERIM REPORT 中期報告 目錄 公司資料 2 財務摘要 4 管理層討論及分析 5 企業管治及其他資料 16 獨立審閱報告 26 中期簡明綜合損益及其他全面收益表 27 中期簡明綜合財務狀況表 28 中期簡明綜合權益變動表 30 中期簡明綜合現金流量表 31 中期簡明綜合財務資料附註 33 釋義 43 2 上海心瑋醫療科技股份有限公司 公司資料 | --- | --- | |----------------------------------------------------|-------------------| | | | | 中文名稱 | 香港主要營業地點 | | ...