Financial Performance - In 2022, the company recorded revenue of RMB 334.1 million, an increase of 87.8% compared to 2021[7]. - The adjusted net loss for 2022 significantly decreased to RMB 25.9 million from RMB 100.7 million in 2021[7]. - The gross profit for 2022 was RMB 252.7 million, up from RMB 131.9 million in 2021[13]. - The pre-tax loss for 2022 was RMB 113.6 million, compared to RMB 199.7 million in 2021[13]. - The total assets as of December 31, 2022, amounted to RMB 3,253.7 million, with non-current assets at RMB 1,191.1 million and current assets at RMB 2,062.6 million[14]. - The total liabilities were RMB 159.5 million, with current liabilities at RMB 152.1 million and non-current liabilities at RMB 7.5 million[14]. - The total equity as of December 31, 2022, was RMB 3,094.2 million, a slight decrease from RMB 3,144.7 million in 2021[14]. - The gross margin improved from 74.1% in 2021 to 75.6% in 2022[31]. - The net loss decreased from RMB 199.7 million in 2021 to RMB 113.6 million in 2022[31]. - The company recorded a net cash outflow from operating activities during the reporting period, indicating potential future financing needs[20]. - The company reported a comprehensive loss for the year ended December 31, 2022, with detailed financial status available on pages 138 to 210 of the financial statements[159]. Product Development and Launches - The company launched a total of 25 products in the Chinese market, with an expectation to obtain over ten additional approvals from the National Medical Products Administration each year for the next three years[8]. - The company launched five new products in 2022, contributing over 1.9% to total revenue for the year[24]. - A total of 25 products have been approved by the National Medical Products Administration, with 8 products receiving CE marking[29]. - The company has strategically developed a total of 57 products and candidates, including 25 approved in China and 8 in Europe[32]. - The company has several products in the pipeline, including the drug-eluting peripheral vascular stent system expected to be launched in 2025 and the peripheral PTA balloon dilation catheter expected to be launched in 2024[37]. - The company has successfully introduced the CRD intracranial thrombectomy stent and is promoting a complete three-piece solution to enhance the success rate and reduce complications in procedures[43]. - The second-generation intracranial aneurysm embolization coil is expected to be launched in 2023, offering more specifications and sizes for treating different sizes of aneurysms[48]. - The company has completed patient enrollment for two clinical trials of its blood flow guiding device in China, despite the negative impact of COVID-19, demonstrating strong R&D and clinical trial execution capabilities[50]. Market Expansion and International Business - The international business contributed revenue of RMB 7.8 million in 2022, a growth of 125.2% from RMB 3.5 million in 2021[9]. - Sales revenue from regions outside of China increased by 125.2% compared to 2021[28]. - The company established a local team in Europe in September 2022 to build long-term partnerships with local doctors and hospitals[9]. - The company aims to enhance local partnerships with doctors through the establishment of its own overseas sales network[28]. - The company is looking to expand its European team and establish a logistics center to improve distribution efficiency in local markets[122]. - Market expansion plans include entering three new international markets by the end of 2023, aiming for a 10% market share in each[141]. Research and Development - The company continues to invest in R&D to expand its product offerings despite the challenges posed by the COVID-19 pandemic[29]. - Research and development expenses for the year were RMB 233.5 million, a 38.9% increase from RMB 168.1 million in the previous year[82]. - The company has established a top-tier independent R&D technology platform to facilitate continuous innovation and technological breakthroughs[68]. - The company is investing heavily in R&D, with a budget allocation of 150 million for the development of innovative medical technologies in 2023[141]. Strategic Goals and Future Outlook - The company aims to become a leading medical device company in China, focusing on providing high-quality and affordable medical products[11]. - The company is committed to enhancing its capabilities and accelerating growth to outperform market trends over the next three to five years[11]. - The company plans to enhance its commercialization capabilities and expand its market share by launching 25 products in China[118]. - The company anticipates leveraging strategic partnerships to drive inorganic growth by acquiring advanced technologies and products[121]. - The company has provided guidance for 2023, projecting revenue growth of 20% to 1.8 billion[141]. Governance and Management - The company was founded in November 2012 by Dr. Zhao, who has 25 years of experience in the pharmaceutical and medical device industry[126]. - The management team includes professionals with advanced degrees in biomedical engineering, management, and finance, contributing to the company's strategic direction[130][136]. - The board includes a mix of executive and independent non-executive directors, ensuring governance and oversight[164]. - The company has established a remuneration committee to determine the compensation policy for directors and senior management based on their experience and qualifications[171]. - The company has arranged appropriate directors' liability insurance for its board members during the reporting period[173]. Shareholder Structure and Ownership - The company has a significant concentration of ownership, with Dr. Zhao controlling voting rights in various employee incentive platforms[183]. - Major shareholders include Dr. Zhong Shengping with 13,476,617 H-shares (4.15%) and 75,143,614 H-shares jointly held (23.15%)[187]. - The company has a diverse shareholder base, including investment management firms and private equity funds[190]. - The employee incentive plan aims to enhance the company's competitiveness in the labor market and attract future senior management[195]. - The company has established four employee incentive platforms, holding a total of 3,637,058 domestic shares and 32,733,529 H-shares as of December 31, 2022[192].

Financial Performance - Revenue for the year ended December 31, 2022, was RMB 334.1 million, an increase of 87.8% compared to RMB 177.9 million in 2021[2] - Gross profit for the same period was RMB 252.7 million, representing a 91.6% increase from RMB 131.9 million in 2021[2] - Gross margin improved to 75.6% in 2022 from 74.1% in 2021, reflecting enhanced operational efficiency[2] - The net loss before income tax decreased to RMB 113.6 million in 2022 from RMB 199.7 million in 2021, a reduction of 43.1%[2] - Non-IFRS adjusted net loss for 2022 was RMB 25.9 million, a significant improvement from RMB 100.7 million in 2021, marking a 74.3% reduction[2] - Operating loss narrowed to RMB 208,398 thousand in 2022 from RMB 212,476 thousand in 2021, showing a slight improvement in operational efficiency[6] - Financial income increased significantly to RMB 95,565 thousand in 2022 from RMB 13,094 thousand in 2021, reflecting enhanced financial management[6] - Net loss attributable to equity holders for the year was RMB 113,555 thousand, an improvement from RMB 199,689 thousand in 2021, resulting in a loss per share of RMB 0.34 compared to RMB 0.68 in the previous year[6] Product Development and Launches - The company launched five new products in 2022, contributing over 1.9% to total revenue for the year[3] - The company has developed a total of 57 products and candidates, including 25 approved in China and 8 in Europe[39] - The company’s neurovascular intervention product lineup includes 8 products expected to be commercialized in 2023, with additional products planned for 2024 and 2025[40] - The peripheral vascular intervention product lineup includes 5 products expected to be commercialized in 2023, with further products planned for 2024, 2025, and 2027[41] - The company is preparing for MDR registration for multiple products, indicating a focus on expanding its market presence in Europe[42] - The company plans to launch a second-generation drug-eluting PTA balloon catheter in 2024[42] - The company has obtained regulatory approval for 13 neurovascular intervention products and expects an additional 15 products to be approved by the end of 2025[43] Market Expansion - Sales revenue from outside China grew by 125.2% compared to the previous year, indicating successful international market expansion[4] - The geographical revenue breakdown shows that sales in China were RMB 326,294,000, up 87% from RMB 174,450,000 in 2021, while revenue from other regions increased to RMB 7,796,000 from RMB 3,462,000[18] - The company is currently focused on expanding its market presence in neurovascular and peripheral vascular intervention medical devices, with ongoing assessments of new product developments and market strategies[14] - The company intends to continue investing in international markets, including expanding its European team and establishing a logistics center[88] Operational Efficiency - The company established a distribution network covering over 3,300 hospitals across 31 provinces and municipalities in China[3] - The company actively participated in provincial volume-based procurement (VBP) tenders, achieving competitive rankings in several provinces[3] - Sales and distribution expenses as a percentage of total revenue decreased significantly from 53.5% as of December 31, 2021, to 41.9% as of December 31, 2022[59] - Employee benefits expenses increased by 52.7% to RMB 130.2 million, up from RMB 85.3 million, representing 55.8% of total R&D expenses[69] Research and Development - Research and development expenses for the year ended December 31, 2022, amounted to RMB 233.5 million, a 38.9% increase from RMB 168.1 million for the year ended December 31, 2021[68] - The company completed patient enrollment for clinical trials of five products in 2022, with 13 candidate products currently in clinical trial stages[60] - The company is actively pursuing clinical trials and regulatory approvals to enhance its product offerings in both domestic and international markets[41] Financial Position - Non-current assets totaled RMB 1,191,097 thousand as of December 31, 2022, a substantial increase from RMB 224,078 thousand in 2021, indicating significant investment in long-term assets[7] - Current assets decreased to RMB 2,062,599 thousand in 2022 from RMB 3,024,208 thousand in 2021, primarily due to a reduction in cash and cash equivalents[7] - The company's net current assets decreased by 34.7% to RMB 1,910.5 million as of December 31, 2022, down from RMB 2,927.1 million in 2021[81] - Cash and cash equivalents as of December 31, 2022, were RMB 1,205.3 million, down from RMB 1,418.4 million as of December 31, 2021[80] Corporate Governance - The audit committee, consisting of three independent non-executive directors, reviewed the annual financial performance for the year ended December 31, 2022, and found it compliant with relevant accounting standards[92] - The company’s auditor confirmed that the preliminary announcement figures align with the audited consolidated financial statements for the year ended December 31, 2022[93] - The board of directors decided not to recommend a final dividend for the year ended December 31, 2022[94] Future Outlook - The company aims to enhance its market share in the neurovascular and peripheral vascular interventional medical device industry by launching 25 new products in China[85] - The company is actively seeking advanced technologies and products through acquisitions and licensing to meet market demands[87]

Financial Performance - The company reported revenue of RMB 152.7 million for the six months ended June 30, 2022, representing a 113.7% increase compared to RMB 71.5 million in the same period of 2021[6]. - Gross profit for the same period was RMB 115.5 million, up 121.5% from RMB 52.1 million in 2021, with a gross margin of 75.6% compared to 72.9% in the previous year[6][8]. - The net loss before income tax decreased to RMB 25.5 million from RMB 69.7 million in the first half of 2021, a reduction of 63.4%[6][8]. - The company achieved a non-IFRS adjusted profit of RMB 8.6 million in the first half of 2022, compared to a non-IFRS adjusted loss of RMB 21.4 million in the same period of 2021[6][8]. - The adjusted net profit for the first half of 2022 was RMB 8.6 million, compared to an adjusted net loss of RMB 21.4 million in the first half of 2021[10]. - Sales revenue for neurovascular intervention products increased by 160.1% compared to the same period in 2021, driven by market penetration and recovery from COVID-19[32]. - Sales revenue for peripheral vascular intervention products rose by 43.9% compared to the same period in 2021, due to efforts in market access and distribution network expansion[33]. Product Development and Regulatory Approvals - The company received approval for two products from the National Medical Products Administration during the reporting period and completed patient enrollment for two clinical trials[7]. - As of the report date, the company had a total of 17 products approved by the National Medical Products Administration and eight products with CE marking, establishing it as a leading company in China's vascular intervention medical device industry[7]. - The product pipeline includes 55 products and candidates, with 17 approved in China and 8 approved in Europe[11]. - The company has launched several products, including the intracranial aneurysm embolization coil and carotid balloon dilation catheter, contributing to its expanding product portfolio[10]. - New products expected to be commercialized include the full-view thrombectomy stent in 2023 and the intracranial drug-coated balloon dilation catheter in 2024[12]. - The company has launched the UltraFree® drug-eluting PTA balloon dilatation catheter and the peripheral PTA balloon dilatation catheter, both of which are already on the market[13]. - The company has a total of 10 neurovascular intervention products that have obtained Class III registration, with an additional 16 products expected to be approved by the end of 2025[16]. Research and Development - Research and development expenses rose by 92.0% to RMB 94.0 million, driven by increased R&D activities and clinical trials[44]. - The company has 13 products currently in clinical trials, demonstrating a commitment to innovation and product development[34]. - The company aims to enhance R&D capabilities by recruiting more talent and collaborating with key opinion leaders and top hospitals[65]. - The company is focused on enhancing product quality and manufacturing efficiency through integrated R&D and manufacturing processes[10]. Manufacturing and Operational Efficiency - The company continues to enhance product quality and manufacturing efficiency, leading to an increase in gross margin[8]. - The company continues to expand its manufacturing capabilities in Hangzhou and Zhuhai to support growth and efficiency[10]. - The manufacturing capacity is being expanded with a new facility of approximately 20,000 square meters in Zhuhai and an additional 13,000 square meters in Hangzhou[35]. - The company plans to streamline its integrated platform to improve operational efficiency and reduce costs[68]. Shareholder Information and Corporate Governance - The company emphasizes the importance of good corporate governance and has adopted relevant codes and practices to maintain high standards[71]. - The company has established a consensus action agreement among shareholders to control decision-making and management, effective from the date of the agreement[90]. - The company has a significant number of shares held by various partnerships, indicating a diverse shareholder base[86]. - The company is subject to regulatory oversight under the Securities and Futures Ordinance, which governs the disclosure of shareholder interests[90]. Cash Flow and Financial Position - As of June 30, 2022, cash and cash equivalents were RMB 1,057.1 million, a decrease of 25.5% from RMB 1,418.4 million as of December 31, 2021[56]. - The company's debt-to-equity ratio as of June 30, 2022, was 0.4%, an increase of 33.3% from 0.3% as of December 31, 2021[57]. - The company reported a total cash flow from operating activities of RMB (86,352) thousand, compared to RMB 36,186 thousand in the previous year[110]. - The company’s financing activities resulted in a net cash outflow of RMB (26,883) thousand, a significant decrease from a net inflow of RMB 477,206 thousand in the previous year[110]. Future Outlook and Strategic Plans - The company aims to further develop its integrated R&D and manufacturing platform to support future growth[8]. - The company plans to expand its product portfolio with an additional six products expected to receive regulatory approval in 2022 and more candidates by 2025[64]. - The company intends to strengthen commercialization capabilities to accelerate sales of approved products and late-stage candidates[67]. - The company plans to establish a European office to enhance brand awareness and responsiveness to local partners and customers[69].

Financial Performance - In 2021, the company achieved a revenue of RMB 177,912 thousand, a significant increase from RMB 27,631 thousand in 2020, representing a growth of approximately 543%[23] - The gross profit for 2021 was RMB 131,881 thousand, compared to RMB 16,287 thousand in 2020, indicating a growth of about 709%[23] - The company reported a loss before tax of RMB (199,689) thousand in 2021, worsening from a loss of RMB (100,468) thousand in 2020[23] - The company reported a revenue of RMB 177.9 million for the year ended December 31, 2021, representing a 543.9% increase compared to RMB 27.6 million for the year ended December 31, 2020[69] - Sales from neurovascular intervention devices accounted for 63.1% of total revenue, while peripheral vascular intervention devices accounted for 36.9%[72] - The cost of sales for the year ended December 31, 2021, was RMB 46.0 million, up 305.8% from RMB 11.3 million for the year ended December 31, 2020[74] - Gross profit increased by 709.7% to RMB 131.9 million, with a gross margin rising from 58.9% to 74.1%[75] - Research and development expenses for the year ended December 31, 2021, were RMB 168.1 million, a 133.3% increase from RMB 72.1 million for the year ended December 31, 2020[76] - Sales and distribution expenses rose by 365.8% to RMB 95.3 million, while the percentage of these expenses to total revenue decreased from 58.9% to 44.6%[78] - Administrative expenses increased by 224.6% to RMB 100.6 million, primarily due to financing activities and increased employee benefits[79] - Other income for the year ended December 31, 2021, was RMB 15.3 million, a 52.9% increase from RMB 10.0 million for the year ended December 31, 2020[81] - Financial income for the year ended December 31, 2021, was RMB 12.8 million, an increase from a financial cost of RMB 0.3 million for the year ended December 31, 2020[83] - The company reported a net loss of RMB 199.7 million for the period, compared to a loss of RMB 100.5 million in the previous year, resulting in an adjusted net loss of RMB 100.7 million[85] Asset Growth - The total assets increased to RMB 3,248,286 thousand in 2021 from RMB 503,971 thousand in 2020, marking a growth of approximately 543%[24] - Non-current assets rose to RMB 224,078 thousand in 2021, up from RMB 133,829 thousand in 2020, reflecting an increase of about 67%[24] - Cash and cash equivalents increased by 2,281.6% to RMB 1,418.4 million as of December 31, 2021, up from RMB 59.6 million in the previous year[87] - The company's current assets net worth rose by 819.0% to RMB 2,927.1 million as of December 31, 2021, compared to RMB 318.5 million at the end of 2020, primarily due to the IPO and C+ round financing[89] - The debt-to-equity ratio decreased significantly from 8.1% as of December 31, 2020, to 0.3% as of December 31, 2021, due to the repayment of all outstanding bank loans[88] Product Development and Innovation - The company maintained a 100% success rate in product registration approvals in 2021, achieving eight approvals from the National Medical Products Administration and two CE market approvals[22] - The company expanded its product portfolio in the vascular intervention field, introducing new devices for treating venous compression syndrome and deep vein thrombosis[22] - The company is committed to continuing its tradition of product and technology innovation in the coming years[22] - The company identified significant potential in the venous thromboembolism (VTE) market and developed a mechanical thrombectomy device for pulmonary embolism (PE), submitting it for inspection in 2021[29] - The company has a comprehensive product portfolio that includes neurovascular and peripheral vascular intervention devices[35] - The company has launched several key products, including the UltraFree® drug-eluting PTA balloon dilatation catheter, which is already on the market[39] - The company expects to commercialize additional products, with 15 new neurovascular intervention products anticipated to be approved by the end of 2025[41] - The company has obtained Class III registration for ten neurovascular intervention products, with four currently in clinical stages[41] - The company has several products in the pipeline, including the peripheral vascular stent system expected to launch in 2023[38] - The company is developing a flow diversion device for treating intracranial aneurysms, with clinical trials ongoing in China and plans for CE marking application[52] Market Expansion and Strategy - The company plans to continue expanding its overseas sales network, having successfully commercialized products in 11 countries across three continents by the end of 2021[30] - The company is preparing to establish a local team in Europe to assist in launching new products and brand building, aiming to enhance its capabilities and achieve long-term strategic goals[31] - The company is actively seeking partners in Europe and the United States with distribution channels and customer resources to accelerate overseas sales[31] - The company aims to increase market penetration by expanding its product offerings to cover more indications in the neuro and peripheral vascular fields[102] - The company plans to utilize various financing channels, including internal funds and bank loans, to support capital expenditures for market expansion[96] Research and Development - The company intends to enhance its research and development capabilities by expanding its R&D team and improving the efficiency of the entire development process[102] - The company is focused on expanding its market presence with new product launches and technological advancements in neurovascular intervention[41] - The company has established strong partnerships with key opinion leaders and top doctors in the neuro and peripheral vascular intervention fields, enhancing its brand recognition[68] - The company has a rich pipeline of 55 products at various stages of development, with 12 products undergoing clinical trials[102] Governance and Leadership - The company was founded in November 2012 by Dr. Zhao, who has 25 years of experience in the pharmaceutical and medical device industry[108] - The company has a strong leadership team with executives holding advanced degrees in biomedical engineering and business administration[110] - The board includes experienced professionals from various sectors, providing strategic guidance for business operations[112] - The company has been involved in significant investments and partnerships to strengthen its market position[111] - The leadership team has a diverse background in healthcare investment banking and medical device management[112] Shareholder and Equity Information - The company completed its IPO on July 5, 2021, raising approximately HKD 2,477.4 million from the issuance of 60,000,000 new H-shares at HKD 42.70 per share[123] - The company has a total of 201,881,003 domestic shares issued, excluding any shares to be issued under the pre-IPO share option plan[141] - The company has established action agreements among major shareholders to control decision-making processes[142] - The company’s governance structure includes significant shareholding by key executives, enhancing alignment with shareholder interests[144] - The total number of shares held by major shareholders indicates a significant concentration of ownership within the company[147][148][149] Compliance and Risk Management - The company has established compliance policies and procedures to ensure adherence to applicable laws and regulations[194] - The company is subject to strict regulatory oversight in the medical device industry, which may affect the approval and commercialization of its candidate products[101] - The company faces significant competition in the medical device market, which may impact its ability to commercialize candidate products successfully[98] - The company is exposed to risks related to natural disasters, health pandemics, and regulatory changes that could adversely affect its business operations[100] Employee and Incentive Plans - The company emphasizes the importance of employees as valuable assets and provides training and competitive compensation to retain them[195] - The employee incentive plans established by the company include four platforms holding a total of 36,370,587 domestic shares as of December 31, 2021[154] - The purpose of the employee incentive plans is to enhance the company's competitiveness in the labor market and attract future senior management[155] - The employee incentive plan allows selected participants to receive economic benefits in the form of equity interests, with the condition that they meet certain vesting criteria[158]