Financial Performance - Revenue for the first half of 2024 reached RMB 365.99 million, a 59.0% increase compared to RMB 230.13 million in the same period of 2023[2] - Gross profit for the first half of 2024 was RMB 260.91 million, up 52.9% from RMB 170.65 million year-on-year[2] - The company reported a net profit of RMB 68.87 million, a significant turnaround from a loss of RMB 35.51 million in the first half of 2023, representing a 293.9% increase[2] - The company achieved an adjusted net profit of RMB 78.17 million, a substantial increase of 1,515.6% compared to a loss of RMB 5.52 million in the previous year[2] - Operating profit for the first half of 2024 was RMB 36.6 million, a significant improvement from an operating loss of RMB 74.13 million in the same period of 2023[8] - The company reported a profit attributable to equity holders of RMB 68,865 thousand for the six months ended June 30, 2024, compared to a loss of RMB 35,514 thousand in the same period of 2023[23] - Basic earnings per share for the six months ended June 30, 2024, was RMB 0.2125, a significant improvement from a loss per share of RMB 0.1077 in the prior year[24] Revenue Breakdown - Sales from neurovascular intervention products increased by 46.7% year-on-year, driven by the growth of key products such as the Silver Snake intracranial support catheter and the Dragon CRD[3] - Sales from peripheral vascular intervention products surged by 88.2% year-on-year, attributed to the rapid growth of products like the UltraFree drug-eluting PTA balloon catheter[3] - Revenue from neurovascular intervention devices was RMB 243,510 thousand, up from RMB 166,038 thousand, reflecting a growth of 46.5% year-over-year[16] - Revenue from peripheral vascular intervention devices reached RMB 120,635 thousand, compared to RMB 64,093 thousand in the previous year, marking an increase of 88.3%[16] - Revenue from neurovascular intervention products accounted for 66.9% of total sales, increasing by 46.7% year-on-year, driven by key products like the Silver Snake intracranial support catheter and the Phoenix intracranial PTA balloon dilation catheter[73] - Revenue from peripheral vascular intervention products surged by 88.2% year-on-year, contributing 33.1% to total sales, attributed to the rapid growth of products like the UltraFree drug-eluting PTA balloon[73] International Business - International business revenue reached RMB 11.5 million, marking an 84.2% increase compared to the same period in 2023, primarily from Europe and Asia[5] - The company is actively expanding its international presence, with dedicated resources for international expansion in R&D, regulatory affairs, and production[5] - The company has received approvals for its products in overseas markets, including the Jiao Long thrombectomy stent and intracranial thrombectomy catheter in regions such as the EU, UK, Turkey, South Africa, Argentina, and Russia[44] Product Development and Launches - The company has launched 44 products in the Chinese market, solidifying its leading position in the neurovascular and peripheral vascular intervention medical device industry[4] - The company launched 37 medical device products in the Chinese market since early 2021, averaging five new products every six months[6] - The company has a total of 63 products and candidates strategically positioned, with 44 products commercialized in China and eight products receiving CE marking in the European Economic Area[41] - The company has successfully launched several innovative products to meet unmet clinical needs, including the CRD thrombectomy stent and ZYLOX Penguin venous stent system[98] Research and Development - R&D expenses decreased by 22.4% to RMB 101.5 million in the first half of 2024 compared to the same period in 2023[7] - The company is actively engaged in research and development to enhance its product offerings[111] - The company is focused on enhancing operational efficiency while organically increasing revenue[36] Operational Efficiency - The gross margin remained stable at 71.3% in the first half of 2024, attributed to continuous optimization of production and supply chain[7] - Sales and distribution expenses as a percentage of total revenue decreased from 32.6% in the first half of 2023 to 21.9% in the first half of 2024[7] - Administrative expenses decreased by 13.4% to RMB 43.6 million, with the percentage of total revenue dropping significantly from 21.9% to 11.9%[80] Corporate Governance and Shareholder Information - The company is committed to maintaining high standards of corporate governance and has adopted practices in line with the Corporate Governance Code[102] - The board has been authorized to repurchase up to 32,461,974 H shares, representing 10% of the total issued H shares as of June 6, 2023, with 108,000 shares repurchased during the reporting period[100] - The total cost for the repurchased shares amounted to HKD 971,090, with a maximum price of HKD 9.5 per share[101] - The company does not plan to declare any interim dividends for the reporting period[106] Market Trends and Future Outlook - The company anticipates that the revenue from unfulfilled contracts will be recognized within one year, indicating a positive outlook for future earnings[17] - The company plans to continue expanding its market share in the neurovascular and peripheral vascular interventional device industry, leveraging its strong commercialization and distribution capabilities[96] - Significant progress has been made in international markets, with ongoing efforts to enhance sales outside of China and strengthen partnerships with local doctors and distributors[97]

| --- | --- | --- | |-------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 即时点评 | 神经、外周介入龙头，业绩持续快速增长 | | | 归创通桥-B（2190.HK） | 2024-07-30 星期二 | | | | 事件： | | | | 公司盈利预告： 2024 上半年营业收入不少于 3.6 亿，与 2023 年同期 | | | | 相比，收入从人民币 2.3 亿元增加了不少于 56.5%。公司净利润不少 | | | | 于人民币 50.0 百万元。 | | | | 点评观点： | | | | ➢ 业绩快速增长 | | | 相关报告 | 公司是国内在神经和外周血管介入医疗器械领域的领导者，集研产销 ...

Investment Rating - The report assigns an initial investment rating of "Buy" for the company [1]. Core Insights - The company is positioned in two high-potential sectors: neurointervention and peripheral intervention, entering a product harvest phase with a comprehensive product ecosystem [1]. - The neurointervention market is expected to exceed 30 billion yuan in five years, with the company actively increasing its market share through competitive pricing strategies [1]. - The company has achieved significant revenue growth, with a projected revenue of 7.57 billion yuan in 2024, reflecting a year-on-year increase of 43.4% [1][3]. Summary by Sections Company Overview - The company, established in 2012, is a leader in the domestic neuro and peripheral vascular intervention medical device sector, offering a comprehensive range of products [7]. - It has developed a robust product pipeline with 43 products approved by NMPA and 8 by CE, with plans to enter the US market [7][20]. Financial Performance - The company reported revenues of 528 million yuan in 2023, a 58% increase year-on-year, and is expected to turn profitable in 2024 [13][3]. - The adjusted net profit for 2023 was 7.03 million yuan, marking the first profitable year [13]. Market Position and Strategy - The company has a complete product ecosystem in neurointervention, with a focus on innovative products that have gained market recognition [20]. - It is expanding its market presence through strategic partnerships and product approvals, including recent approvals for new peripheral intervention products [21]. Growth Projections - Revenue is projected to grow significantly, with estimates of 7.57 billion yuan in 2024, 10.19 billion yuan in 2025, and 13.51 billion yuan in 2026, indicating a strong growth trajectory [3]. - The company aims to maintain a high gross margin above 70%, with continuous improvements in operational efficiency [17].

Market Performance and Growth - The company has received approval for 43 products in the Chinese market, achieving a 72.2% annualized growth over the past three years, with nearly 300,000 products in use across various hospitals[11]. - Revenue increased from RMB 7.8 million in 2022 to RMB 14.3 million in 2023, indicating a significant growth trajectory in international sales[14]. - The company views 2024 as a pivotal year for growth, aiming to leverage its competitive advantages to achieve profitability and scale[14]. - In 2023, the company's revenue reached RMB 527,754 thousand, a significant increase of 58% compared to RMB 334,090 thousand in 2022[16]. - Revenue from regions outside China reached RMB 14.3 million in 2023, representing an 83.1% increase compared to 2022[32]. - The company reported a compound annual growth rate (CAGR) of 72.2% in total revenue from 2021 to 2023, indicating strong market expansion in the neurovascular and peripheral vascular intervention device sectors[86]. Product Development and Innovation - The company aims to expand its product registrations to over 20 countries/regions, with plans to enter Southeast Asia, South America, and North Asia in 2024[14]. - The company has established a strategic layout for its product pipeline, with various products expected to be commercialized in the coming years[35]. - The company launched the ZYLOX Penguin stent system in 2023, featuring innovative design elements aimed at reducing thrombosis risk and improving vascular compliance[27]. - The company launched five new products in the peripheral venous disease treatment sector over the past 24 months, strengthening its market presence and distribution partnerships[30]. - The company is actively promoting the BADDASS thrombectomy technique, which combines a balloon guide with a large bore distal access catheter[41]. - The company expects to expand the indications for the UltraFree DCB, currently enrolling patients for clinical trials on below-the-knee applications[50]. Financial Performance - The gross profit before tax loss was RMB 384,988 thousand, with a gross margin of approximately 73%[16]. - The adjusted profit for the year was RMB 7,033 thousand, a turnaround from a loss of RMB 25,877 thousand in 2022[16]. - Non-current assets increased to RMB 1,658,520 thousand in 2023, up from RMB 1,191,097 thousand in 2022, reflecting a growth of 39.2%[17]. - Current assets decreased to RMB 1,717,181 thousand in 2023 from RMB 2,062,599 thousand in 2022, a decline of 16.7%[17]. - Total assets amounted to RMB 3,375,701 thousand in 2023, compared to RMB 3,253,696 thousand in 2022, indicating a growth of 3.7%[17]. - The company's gross profit increased by 52.4% to RMB 385.0 million, while the gross profit margin slightly decreased to 72.9% from 75.6% in the previous year[63]. Operational Efficiency and Cost Management - The company emphasizes continuous cost optimization while maintaining investment in innovation to provide affordable medical products[13]. - The company has invested in strategic digitalization and automation to enhance operational efficiency and R&D capabilities[12]. - The company is focused on improving its operational mechanisms and reporting tools to ensure better coordination across its business[12]. - Sales and distribution expenses as a percentage of total revenue decreased from 41.9% in 2022 to 31.0% in 2023, reflecting enhanced sales and marketing efficiency[26]. - R&D expenses as a percentage of total revenue decreased from 69.9% in 2022 to 49.5% in 2023, while the absolute amount increased from RMB 233.5 million to RMB 261.0 million[26]. Strategic Partnerships and Collaborations - The company has established a robust ecosystem of partnerships with doctors, hospitals, distributors, and suppliers to enhance its competitive advantage[11]. - A strategic partnership with Avinger Inc. was established in March 2024 to introduce innovative peripheral vascular devices to the Chinese market, enhancing the company's product portfolio[28]. - The company is actively evaluating opportunities to enter other potential markets and plans to allocate more resources to strengthen its international business[32]. Risks and Challenges - The company faces significant risks related to product commercialization and competition in the medical device market[19]. - Future growth is heavily dependent on the successful development and commercialization of candidate products[19]. Shareholder Structure and Management - The company has a significant concentration of ownership, with several shareholders holding over 20% of the H shares[130]. - The company is under the control of a concert party agreement, which influences decision-making and management[125]. - The company has established employee incentive platforms that hold significant shares in the company[125]. - The company’s senior management team includes experienced professionals with extensive backgrounds in finance and regulatory affairs[100]. Compliance and Governance - The company has not identified any significant violations of laws and regulations related to its business, including environmental, health and safety, and employment laws[107]. - The audit committee, consisting of three independent non-executive directors, reviewed the audited consolidated financial statements for the year ending December 31, 2023[197]. - The independent auditor, PwC, will be reappointed for the next fiscal year, pending shareholder approval at the upcoming annual general meeting[198].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 16.0, indicating a potential upside of 68% from the current price [4]. Core Insights - The company's revenue growth for 2023 slightly exceeded expectations, with a year-on-year increase of 58% to RMB 528 million, surpassing the guidance of over RMB 500 million [1][2]. - The gross margin experienced a slight decline of 3.5 percentage points to 72.9% due to price reductions from centralized procurement, but the company expects to improve its net profit margin to approximately 14% by 2025 through scale effects and operational efficiency [1][2]. - The company achieved its first profit under adjusted net income, reporting RMB 7.03 million, compared to a net loss of RMB 78.73 million under IFRS [1][2]. Revenue and Profit Forecast - The company forecasts a revenue increase of 43% in 2024, reaching RMB 756 million, with a net profit of RMB 72.1 million, resulting in a net profit margin of 9.5% [2][3]. - The projected compound annual growth rate (CAGR) for revenue from 2023 to 2026 is estimated at 38% [2]. Product Approval and Market Position - The company anticipates the approval of two key products, the mesh stent and peripheral vascular sutures, within 2024, which are expected to drive further revenue growth [1][2]. - The company’s neurointervention business saw a revenue increase of 64% in 2023, with core products maintaining a leading market share [1][2]. Market and Competitive Landscape - The company’s core products, including the "Jiaolong" thrombectomy stent and "Yin She" intracranial support catheter, were successfully selected in the Beijing-Tianjin-Hebei centralized procurement, which is expected to enhance market share [1][2]. - The company has entered a strategic partnership with Avinger for peripheral intervention products, with expected approval in 2025 and projected revenue contribution of at least RMB 20 million in 2026 [2]. Financial Metrics - The report provides a financial outlook with projected revenues and net profits for the years 2024 to 2026, indicating a recovery trajectory with net profits expected to reach RMB 237 million by 2026 [3][8]. - The price-to-sales (P/S) ratio is projected to decrease from 5.5x in 2023 to 2.1x in 2026, reflecting anticipated growth in revenue [3][9].

Financial Performance - For the year ended December 31, 2023, the company reported revenue of RMB 527.8 million, a 57.6% increase from RMB 334.1 million in 2022[2]. - The gross profit margin decreased to 72.9% in 2023 from 75.6% in 2022, while the adjusted net profit for the year was RMB 7.0 million, a significant improvement from a loss of RMB 25.9 million in 2022[2][3]. - The company reported a revenue of RMB 527.754 million for the year ended December 31, 2023, an increase from RMB 334.090 million in 2022, representing a growth of approximately 58%[8]. - Gross profit for the year was RMB 384.988 million, compared to RMB 252.669 million in the previous year, indicating a significant increase of around 52%[8]. - The company recorded a significant operating loss of RMB 156.523 million for the year, an improvement from a loss of RMB 208.398 million in 2022[8]. - The company reported a net loss attributable to equity holders of RMB 78,734,000 for the year ended December 31, 2023, compared to a net loss of RMB 113,555,000 in 2022, reflecting a reduction in losses of approximately 31%[29]. - The basic and diluted loss per share for the year ended December 31, 2023, was RMB 0.24, compared to RMB 0.34 in 2022, showing an improvement in per-share performance[29]. - The company reported a cumulative loss of RMB 481,907 thousand in 2023, compared to RMB 403,173 thousand in 2022, indicating an increase in losses of approximately 19.5%[9]. Revenue Growth - Sales revenue from neurovascular intervention products increased by 63.6% in 2023, driven by the recognition of product quality and clinical performance[3]. - Sales revenue from peripheral vascular intervention products rose by 43.7% in 2023, attributed to expanded market access and enhanced distribution networks[3]. - Revenue from product sales for the year ended December 31, 2023, was RMB 527,754 thousand, up from RMB 334,090 thousand in 2022, indicating a growth of approximately 58%[18]. - Revenue from China for the year ended December 31, 2023, was RMB 513,482,000, up from RMB 326,294,000 in 2022, indicating a growth of about 57%[22]. - Revenue from regions outside of China reached RMB 14.3 million in 2023, representing an 83.1% increase compared to 2022[43]. Cost and Expenses Management - The percentage of sales and distribution expenses to total revenue decreased from 41.9% in 2022 to 31.0% in 2023, reflecting improved sales and marketing efficiency[4]. - Research and development expenses as a percentage of total revenue decreased from 69.9% in 2022 to 49.5% in 2023, with R&D spending increasing from RMB 233.5 million to RMB 261.0 million[4]. - Administrative expenses as a percentage of total revenue fell from 32.7% in 2022 to 21.6% in 2023, indicating enhanced operational efficiency[4]. - The company's cost of sales for the year ending December 31, 2023, was RMB 142.8 million, a 75.3% increase from RMB 81.4 million in the previous year, primarily due to increased raw material costs and employee benefits[70]. Product Development and Innovation - The company plans to launch innovative products, including the ZYLOX Penguin stent system, to strengthen its market position in the peripheral vascular intervention segment[4]. - The company launched five new products in the peripheral venous disease treatment sector over the past 24 months, enhancing its competitive advantage in the market[6]. - The company is actively upgrading existing products to meet diverse clinical needs, launching second-generation products for several existing offerings[5]. - The company has successfully launched innovative products to meet unmet clinical needs, including the CRD and ZYLOX Penguin systems[91]. - The company has a comprehensive product portfolio in peripheral vascular intervention, covering stents, balloons, catheters, and filters[56]. Market Expansion - The company expanded its international footprint to 19 countries, with revenue from outside China reaching RMB 14.3 million, a growth of 83.1% compared to 2022[7]. - The company plans to continue expanding its product offerings in the neurovascular and peripheral vascular intervention medical device market, focusing on innovation and market penetration strategies[12]. - The company is actively assessing opportunities to enter other potential markets and plans to allocate more resources to strengthen its international business[43]. - The company has entered into a series of licensing and investment agreements with Avinger Inc., committing to invest a total of $15.0 million in two phases, contingent upon achieving certain milestones[99]. Financial Position - Total assets as of December 31, 2023, amounted to RMB 3,375,701 thousand, an increase from RMB 3,253,696 thousand in 2022, reflecting a growth of approximately 3.7%[9]. - Non-current assets increased significantly to RMB 1,658,520 thousand in 2023 from RMB 1,191,097 thousand in 2022, representing an increase of about 39.2%[9]. - The company's total equity decreased slightly to RMB 3,047,385 thousand in 2023 from RMB 3,094,153 thousand in 2022, a decline of about 1.5%[9]. - Current liabilities rose to RMB 317,783 thousand in 2023, compared to RMB 152,084 thousand in 2022, marking an increase of approximately 109%[11]. - The total liabilities increased to RMB 233,886,000 in 2023 from RMB 126,652,000 in 2022, representing an increase of approximately 84%[33]. Governance and Compliance - The audit committee, consisting of three independent non-executive directors, has reviewed the annual financial performance for the year ended December 31, 2023, and found it compliant with relevant accounting standards[100]. - The auditor, PwC, confirmed that the figures in the preliminary announcement align with the audited consolidated financial statements for the year ended December 31, 2023[101]. - The board of directors has decided not to recommend a final dividend for the year ended December 31, 2023, compared to no dividend in 2022[102].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 230.1 million, representing a 50.7% increase from RMB 152.7 million in the same period of 2022[6]. - Gross profit for the same period was RMB 170.6 million, up 47.8% from RMB 115.5 million year-on-year, with a gross margin of 74.2%[6]. - The company reported a loss of RMB 35.5 million for the period, a 39.2% increase compared to a loss of RMB 25.5 million in 2022[6]. - The adjusted net loss, excluding share-based compensation, was RMB 5.5 million, compared to a profit of RMB 8.6 million in the previous year[6]. - Revenue from neurovascular intervention products accounted for 72.1% of total revenue, while peripheral vascular intervention products contributed 27.9%[8]. - Revenue from international markets reached RMB 6.2 million in the first half of 2023, a 128.7% increase compared to the same period in 2022[13]. - The company reported a total revenue from external customers for the six months ended June 30, 2023, was RMB 230,131,000, compared to RMB 152,743,000 for the same period in 2022, indicating an overall growth[125]. Market and Industry Insights - The Chinese neuro and peripheral vascular interventional device market is still in its early development stage, with an estimated treatment penetration rate of only 0.2% compared to 5.4% in the U.S.[7]. - The government is actively supporting the development of the neuro and peripheral vascular interventional device market, with over 603 advanced stroke centers established nationwide[7]. - The estimated number of large vessel occlusion AIS-EVT cases in China could reach approximately 300,000, assuming a treatment suitability rate similar to that of the U.S.[7]. - The market for neuro and peripheral vascular interventional devices continues to show significant growth potential due to an aging population and increasing disease prevalence[7]. - The company anticipates that multiple policies will enable leading domestic enterprises with comprehensive product portfolios to gain more market share[7]. Product Development and Innovation - The company has developed a total of 57 products and candidates, including 28 approved in China and 8 in Europe[15]. - The company expects to have an additional 13 neurovascular intervention products approved by the National Medical Products Administration by the end of 2025[18]. - The company has successfully launched the Jiao Long® intracranial thrombectomy stent (CRD), intracranial support catheter, and balloon guiding catheter as a complete solution for treating intracranial ischemic stroke[19]. - The company plans to launch the second-generation intracranial aneurysm embolization coil in 2023, offering more specifications and sizes[23]. - The company is actively promoting the BADDASS thrombectomy technique, which combines multiple devices for enhanced treatment[19]. Research and Development - Research and development expenses rose by 39.1% to RMB 1,308 million from RMB 940 million for the six months ended June 30, 2022, driven by increased testing and clinical trial costs[42]. - The company plans to utilize RMB 941.3 million (40% of the net proceeds) for further upgrading R&D facilities and office expansions by 2025[71]. - The company aims to increase market share through differentiated product positioning and commercialization capabilities in the neurovascular and peripheral vascular interventional device sectors[64]. Financial Position and Cash Flow - As of June 30, 2023, the company's cash and cash equivalents amounted to RMB 1,306.9 million, an increase of 8.4% from RMB 1,205.3 million as of December 31, 2022[53]. - The company's net current assets as of June 30, 2023, were RMB 1,696.1 million, a decrease of 11.2% from RMB 1,910.5 million as of December 31, 2022[56]. - The company reported a net cash used in operating activities for the six months ended June 30, 2023, was RMB (18,523) thousand, an improvement compared to RMB (50,166) thousand for the same period in 2022[106]. - The net cash generated from investing activities was RMB 111,010 thousand for the six months ended June 30, 2023, compared to a net cash used of RMB (290,476) thousand in the same period of 2022, indicating a significant turnaround[106]. Shareholder Structure and Governance - The company has confirmed compliance with the "Standard Code" during the reporting period by all directors and supervisors[68]. - The company has established a governance structure where shareholders act in concert to control decision-making and management[5]. - The company is actively managing its shareholder agreements to ensure alignment in strategic decisions[83]. - The overall ownership percentages suggest a concentrated control structure, which may impact future corporate strategies and decisions[83]. Employee Incentives and Stock Options - The total number of shares available for grant under the employee incentive plans decreased from 2,522,813 shares on January 1, 2023, to 892,529 shares as of June 30, 2023[8]. - The company has granted stock options to key personnel, including Dr. Zhao Zhong with a maximum of 718,282 domestic shares and Dr. Pan Ning with a maximum of 586,597 domestic shares, subject to vesting conditions[8]. - The company aims to achieve specific revenue targets over the next three years as part of its employee incentive plans[90]. Future Outlook - The company plans to expand its market presence in Southeast Asia, targeting a 20% market share by 2025[183]. - Future guidance estimates revenue growth of 20-25% for the second half of 2023, driven by new product launches[183]. - The company is exploring potential acquisitions to strengthen its product portfolio and market position[183].

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 230.1 million, an increase of 50.7% compared to RMB 152.7 million for the same period in 2022[2] - Gross profit for the same period was RMB 170.6 million, up 47.8% from RMB 115.5 million year-on-year, with a gross margin of 74.2%[2] - The company recorded a net loss of RMB 35.5 million for the period, compared to a loss of RMB 25.5 million in the same period last year, reflecting a 39.2% increase in losses[2] - Operating loss for the first half of 2023 was RMB 74.133 million, compared to a loss of RMB 61.376 million in the same period of 2022[7] - The company reported a net loss attributable to equity holders of RMB 35.514 million for the first half of 2023, compared to RMB 25.504 million in the same period of 2022[7] - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.11, compared to RMB 0.08 for the same period in 2022, reflecting an increase in losses[25] - The adjusted loss for the period was RMB 55.22 million, compared to a loss of RMB 86.41 million for the same period in 2022, with non-IFRS adjusted profit/loss amounting to RMB 299.92 million for the current period[73] Revenue Breakdown - Revenue from regions outside China reached RMB 62 million in the first half of 2023, an increase of 128.7% compared to the same period in 2022[6] - Revenue from neurovascular intervention products accounted for 72.1% of total revenue, while peripheral vascular intervention products contributed 27.9%[34] - Sales revenue from neurovascular intervention products increased by 48.7% year-on-year, driven by the recognition of key products such as the Silver Snake® intracranial support catheter[34] - Sales revenue from peripheral vascular intervention products rose by 55.9% year-on-year, attributed to efforts in market access and distribution network expansion[34] Product Development and Market Expansion - The company has established a distribution network covering over 3,300 hospitals across 31 provinces and municipalities in China as of June 30, 2023[3] - The company has 28 products approved by the National Medical Products Administration and eight products with CE marking, making it one of the leading companies in the vascular intervention medical device industry in China[5] - The company launched the Silver Snake® Plus distal access catheter in February 2023, enhancing its product offerings for interventional procedures[4] - The company has expanded its product commercialization to 19 overseas countries, including Germany, France, and Italy[6] - The company is exploring new business models beyond traditional distribution, including providing OEM services in emerging markets like India[6] - The company is focused on enhancing R&D and commercialization efficiency to maintain a competitive edge in the neurovascular and peripheral vascular intervention market[36] Financial Position and Assets - Non-current assets increased to RMB 1,405.297 million as of June 30, 2023, compared to RMB 1,191.097 million at the end of 2022[8] - Current assets totaled RMB 1,891.801 million as of June 30, 2023, down from RMB 2,062.599 million at the end of 2022[8] - Trade receivables as of June 30, 2023, were RMB 964 thousand, slightly down from RMB 1,014 thousand as of December 31, 2022, indicating a minor decrease in receivables[26] - Trade payables increased to RMB 16,348 thousand as of June 30, 2023, compared to RMB 10,735 thousand as of December 31, 2022[30] - The group's cash and cash equivalents were RMB 1,306.9 million, an increase of 8.4% from RMB 1,205.3 million as of December 31, 2022[75] - The group's total borrowings as of June 30, 2023, amounted to RMB 9 million, with an asset-liability ratio of 0.63%, an increase of 39.7% from 0.45% as of December 31, 2022[77] - The group's net current assets as of June 30, 2023, were RMB 1,696.1 million, a decrease of 11.2% from RMB 1,910.5 million as of December 31, 2022[78] Research and Development - R&D expenses increased by 39.1% to RMB 130.8 million, driven by higher testing and clinical trial costs[65] - The company is enhancing its manufacturing capabilities through integrated R&D and manufacturing processes, which are expected to improve product quality and cost efficiency[6] - The company has initiated type testing for the balloon-covered stent system, with an expected launch in China by 2027[53] - The company is expanding its product pipeline with 11 candidate products in clinical stages and 14 in registration stages[37] Corporate Governance and Compliance - The board emphasizes the importance of good corporate governance and has adopted practices in line with the Corporate Governance Code, although there is a noted deviation regarding the roles of the chairman and CEO[86] - The audit committee, consisting of three independent non-executive directors, reviewed the unaudited interim financial information for the six months ending June 30, 2023[88] - The board does not recommend any interim dividend for the reporting period[89] Future Outlook - The company provided a future outlook, projecting a revenue growth of 25% for the next fiscal year, driven by new product launches and market expansion[95] - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share within the next two years[95] - A new product line is expected to launch in Q4 2023, anticipated to contribute an additional RMB 50 million in revenue[95] - The company is exploring potential acquisitions to enhance its product portfolio and market reach, with a budget of up to RMB 200 million allocated for this purpose[95]

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]