Financial Performance - The company reported a net loss of RMB 409.825 million for the fiscal year ended December 31, 2021, compared to a loss of RMB 340.294 million in 2020, representing an increase in loss of approximately 20.4%[8]. - The company reported a net loss of RMB 4,098 million in 2021 compared to RMB 3,403 million in 2020[43]. - The company reported other income and gains of RMB 7.159 million in 2021, an increase from RMB 3.424 million in 2020[8]. - Other income increased from RMB 34 million in 2020 to RMB 72 million in 2021, primarily due to more government subsidies and increased interest income from higher cash balances[29]. - Cash used in operating activities was RMB 885 million as of December 31, 2021, primarily due to significant R&D and administrative expenses incurred during the reporting period[44]. - As of December 31, 2021, the company's cash and cash equivalents increased by 56.2% to RMB 708.5 million from RMB 453.7 million as of December 31, 2020[46]. - The company's net current assets rose from RMB 456.9 million as of December 31, 2020, to RMB 719.7 million as of December 31, 2021, primarily due to cash inflow from the net proceeds of the IPO[46]. - The company's debt remained at zero, with no outstanding borrowings as of December 31, 2021[48]. - The company's lease liabilities increased from RMB 1.3 million as of December 31, 2020, to RMB 22.4 million as of December 31, 2021, due to the increase in right-of-use assets[49]. - The debt-to-asset ratio as of December 31, 2021, was 7.2%, up from 5.2% as of December 31, 2020, attributed to the rise in lease liabilities and other payables[50]. Research and Development - Research and development expenses amounted to RMB 214.228 million in 2021, a decrease of 12.8% from RMB 245.743 million in 2020[8]. - The company has established a product pipeline with nine products at various stages of development, focusing on bioresorbable stents and renal denervation systems[10]. - The company aims to strengthen its internal R&D capabilities and expand its product pipeline while preparing for the commercialization of its in-development products[11]. - The company has nine products in various stages of development, including the Bioheart® fully biodegradable stent system, which is expected to be commercialized in Q3 2023[14]. - The Bio-Leap™ stent system for below-the-knee peripheral vascular disease is currently in animal studies, with clinical trials expected to start in 2023 and product launch anticipated around 2026[17]. - The second-generation Iberis® renal nerve ablation system is undergoing confirmatory clinical trials in China, with commercialization expected in Q2 2023[18]. - The Bioheart® balloon dilation catheters are designed for stent deployment and are expected to launch in Q2 2023, having received exemptions from clinical trial requirements in China[20]. - The Bioheart Ultra™ stent system, a second-generation product for coronary artery disease, is in animal studies with clinical trials expected to start in 2023 and a launch anticipated around 2028[17]. - The company has invested 150 million RMB in new technology for clinical trials, aiming to improve product efficacy and safety[98]. Market Expansion and Strategy - The company is actively expanding its business globally, including clinical trials for the second-generation Iberis® in Europe and Japan[10]. - The company aims to enhance its market share in the Chinese interventional cardiovascular device market and expand its product portfolio[27]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2023[85]. - A strategic acquisition of a local biotech firm is planned to enhance R&D capabilities and product offerings[85]. - The company plans to actively seek external collaborations, strategic investments, and acquisition opportunities to facilitate future expansion[27]. - The management team emphasized a focus on risk management and compliance in their operations moving forward[82]. Corporate Governance - The company has established a robust governance structure with a diverse board of directors overseeing major strategic decisions[74][79]. - The board of directors consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence[104]. - The company has adopted a board diversity policy, considering factors such as gender, skills, age, professional experience, knowledge, cultural and educational background, race, and tenure in selecting board candidates[139]. - The company aims to enhance gender diversity on the board and will actively seek to appoint female directors, ensuring gender diversity in senior management recruitment as well[140]. - The company has established a nomination committee to provide recommendations on the appointment and removal of directors, and to regularly review the board's structure and composition[129]. - The company has confirmed compliance with the standard code of conduct for securities trading by all directors and senior management during the reporting period[107]. - The audit committee was established on December 9, 2020, consisting of three independent non-executive directors, with a primary function to assist the board in financial reporting and risk management[124]. - The remuneration committee was also established on December 9, 2020, to formulate remuneration policies and assess the performance of directors and senior management[125]. - The company has adopted a comprehensive risk management policy to identify, assess, evaluate, and monitor key risks related to its strategic objectives[148]. - The board is responsible for establishing an internal control system and reviewing its effectiveness, ensuring that the system is effective and adequate[152]. Employee and Management - The company employed 50 staff members as of December 31, 2021, with total employee benefit expenses amounting to approximately RMB 334.6 million for the year[56]. - The company aims to increase its workforce by 20% to support growth initiatives and new product launches[85]. - The leadership team includes professionals with advanced degrees from prestigious institutions, enhancing the company's strategic decision-making capabilities[75][76]. - The company has a strong leadership team with members holding significant experience in investment and healthcare sectors, including positions at TPG Capital and Ernst & Young[71][72]. - Senior management compensation details for the year ended December 31, 2021, include one member earning between RMB 190,000,000 and RMB 200,000,000, three members earning between RMB 20,000,000 and RMB 30,000,000, one member earning between RMB 10,000,000 and RMB 20,000,000, and one member earning between RMB 1,000,000 and RMB 10,000,000, totaling six members[127]. Quality Management and Compliance - The company adheres to the Product Quality Law of the People's Republic of China and relevant regulations, ensuring compliance with quality management standards[200]. - The quality management system is established based on GMP standards and ISO 13485:2016, certified in China[200]. - The company conducts annual internal and external audits to identify system weaknesses and promote continuous improvement, with 2 external and 2 internal audits held in 2021[200]. - A dedicated team is responsible for quality assurance, ensuring effective implementation of the quality management system[200]. - All employees responsible for product quality receive internal and external training covering key skills, regulatory requirements, and product knowledge[200]. Shareholder Relations and Dividends - The company emphasizes the importance of effective communication with shareholders to strengthen investor relations and ensure informed investment decisions[176]. - The company currently expects to retain all future profits for business operations and expansion, with no plans to declare or pay any dividends in the near future[177]. - Future dividend declarations will depend on various factors, including profitability, capital requirements, overall financial condition, and contractual restrictions[177]. - The company must first offset past accumulated losses and allocate 10% of net profits to statutory reserves until the reserve reaches over 50% of registered capital before declaring dividends[177].
百心安-B(02185) - 2021 - 年度财报