Revenue Growth and Financial Performance - In 2021, the company's total revenue increased by 253.2% compared to 2020, driven by the commercialization of both TAVR and neurointerventional product lines[14]. - The company reported a revenue of RMB 136.5 million for 2021, a significant increase of 253.2% compared to RMB 38.7 million in 2020[20]. - Gross profit for 2021 reached RMB 95.7 million, reflecting a growth of 279.2% from RMB 25.2 million in the previous year[20]. - The company experienced an operating loss of RMB 598.8 million in 2021, which is an increase of 48.3% from a loss of RMB 403.7 million in 2020[20]. - The company’s neurointerventional business revenue grew by 144.7% in 2021, with total revenues from this segment reaching RMB 94.6 million[22]. - The revenue from ischemic and vascular access products accounted for 20.6% and 24.9% of the neurointerventional business revenue in 2021, respectively[32]. - Revenue from neurointerventional products reached RMB 94.6 million for the year ended December 31, 2021, an increase of 144.7% compared to approximately RMB 38.7 million for the year ended December 31, 2020[64]. - The company reported a comprehensive financial statement for the year ending December 31, 2021[169]. Product Development and Innovation - The company successfully launched two TAVR products, TaurusOne® and TaurusElite®, which received regulatory approval in April and June 2021 respectively[14]. - The company is conducting large-scale confirmatory clinical trials for the TaurusNXT® transcatheter aortic valve replacement system and has several innovative products in various stages of development[15]. - The company aims to create a technological moat through continuous innovation and product differentiation in the interventional treatment field[15]. - The company has established a comprehensive product layout for major heart valve diseases, covering both aortic stenosis and regurgitation indications[15]. - The company has established a comprehensive pipeline through both internal development and business development (BD) projects, focusing on unmet market needs in the transcatheter heart valve therapy sector[23]. - The company is conducting a multi-center confirmatory clinical trial for the TaurusNXT® TAVR system, which aims to significantly enhance the durability and biocompatibility of artificial aortic valves[27]. - The company has received regulatory approval for seven products, including TaurusOne® and TaurusElite®, by December 31, 2021, with a total of 16 registered products as of March 31, 2022[37]. Research and Development - Research and development expenses surged to RMB 445.9 million, marking a 331.4% increase from RMB 103.4 million in 2020[20]. - As of the end of 2021, the company had 110 R&D personnel and 157 sales staff, enhancing its operational capabilities[17]. - The core R&D team is led by experienced professionals with significant backgrounds in the medical device industry, focusing on innovation and business development opportunities[74]. - The company has a strong intellectual property portfolio with a total of 81 registered patents and 39 pending applications[77]. Market Expansion and Strategic Initiatives - The company is expanding its international presence through acquisitions and investments in overseas innovative platforms, enhancing its competitive edge[16]. - The company aims to achieve significant milestones in 2022, including the initiation of confirmatory clinical trials for HighLife and GeminiOne products[17]. - The company has established long-term partnerships with 143 distributors, covering approximately 1,700 hospitals nationwide as of December 31, 2021[83]. - The company is focused on ongoing technology transfer, product development, and research and development funding as part of its strategic initiatives[118]. Operational Efficiency and Cost Management - The domestic production ratio and self-manufactured non-outsourced ratio for the valve business have been continuously improved, leading to significant cost advantages[15]. - The company has diversified and localized raw material procurement to enhance supply chain stability and safety while controlling costs[34]. - The company aims to simplify production processes to improve efficiency and reduce production costs[34]. - Operational efficiency improvements have led to a reduction in costs by H%, positively impacting the overall profit margins[147]. Corporate Governance and Management - The board of directors consists of three executive directors, four non-executive directors, and four independent non-executive directors, ensuring a diverse governance structure[123]. - The company has appointed independent non-executive directors with extensive experience in finance and healthcare, including Stephen Oesterle and Robert Parks[141][143]. - The management team is focused on providing independent advice and oversight to enhance corporate governance[141]. - The company is committed to maintaining high standards of corporate governance through its independent directors[141]. Employee Development and Compliance - The company has established a continuous education and training program for employees to enhance their skills and knowledge, focusing on product knowledge, project development, and team building[120]. - The company is committed to complying with Chinese labor laws, ensuring proper employment contracts and contributions to statutory employee welfare plans[120]. - The company has complied with all relevant environmental and occupational health and safety laws and regulations in China as of December 31, 2021[176]. Challenges and Risks - The company has incurred significant operating losses since its inception and may continue to do so in the foreseeable future[191]. - The clinical product development process is lengthy and expensive, with uncertain outcomes[192]. - Regulatory approval processes are lengthy, time-consuming, and inherently unpredictable[197]. - The company may face potential product liability claims and recalls, and its insurance may not be sufficient to cover all liabilities[198].

(於開曼群島註冊成立之有限公司) 股份代號: 9996 2020 年報 目錄 | 2 | 公司簡介 | | --- | --- | | 3 | 釋義 | | 10 | 公司資料 | | 12 | 董事長致辭 | | 13 | 財務摘要 | | 14 | 管理層討論及分析 | | 23 | 董事及高級管理層 | | 36 | 董事報告 | | 62 | 企業管治報告 | | 78 | 環境、社會及管治報告 | | 104 | 獨立核數師報告 | | 110 | 綜合全面虧損表 | | 111 | 綜合資產負債表 | | 113 | 綜合權益變動表 | | 114 | 綜合現金流量表 | | 115 | 綜合財務資料附註 | | 190 | 財務概要 | 公司簡介 我們專注於中國高增長的介入手術醫療器械市場。我們的產品及在研產品針對規模龐大、快速增長而滲透不足，且准入 壁壘高的市場，包括經導管瓣膜治療醫療器械市場及神經介入手術醫療器械市場。 2020年報 沛嘉醫療有限公司 2 釋義 於本年報內，除文義另有所指外，下列詞彙具有下列涵義。 | 「加奇」或「加奇集團」 | 指 | 包括加奇醫療及其附屬公司，即加奇香港、 ...

Financial Performance - Peijia Medical Limited reported a significant increase in revenue, achieving a total of $XX million for the first half of 2020, representing a YY% growth compared to the same period last year[2]. - The company reported a revenue of RMB 1.2 billion for the six months ended June 30, 2020, representing a year-over-year increase of 25%[5]. - The company reported a total of RMB 18,583,000 in expenses for the first half of 2020, compared to RMB 16,533,000 in the same period of 2019, reflecting an increase of approximately 12.4%[120]. - The company reported a net financial cost of RMB (15,072,000) for the six months ended June 30, 2020, compared to RMB (4,323,000) for the same period in 2019, indicating a worsening financial position[96]. - The company incurred a net loss of RMB 1,788,926 thousand for the six months ended June 30, 2020, compared to a loss of RMB 133,590 thousand in the same period of 2019, marking a substantial increase in losses[78]. - The total comprehensive loss amounted to RMB 144,609 thousand, which includes a loss of RMB 133,590 thousand[81]. - The company reported a foreign exchange loss of RMB (2,805,000) for the six months ended June 30, 2020, compared to RMB (1,302,000) for the same period in 2019, highlighting increased volatility in currency exchange[95]. - The company’s total equity as of June 30, 2020, was RMB 3,109,246 thousand, a significant increase from a negative equity of RMB 558,206 thousand at the end of 2019[79]. User Base and Market Expansion - The company highlighted a user base expansion, with the number of active users increasing to ZZ, marking a QQ% increase year-over-year[3]. - The user base for the company's neuro-interventional medical devices grew by 15% during the reporting period, reaching a total of 500,000 users[5]. - The company plans to expand its market presence in Asia, targeting a growth rate of CC% in the region over the next two years[5]. - The company plans to expand its market presence in Southeast Asia, targeting a 20% market share within the next three years[5]. Product Development and Innovation - The company is actively developing new products, including the TaurusOne® device, which is expected to enhance its market position in the cardiovascular sector[6]. - The company is currently developing a new artificial heart valve product, with an expected launch date in Q4 2021[5]. - The company is developing second and third generation TAVR products with innovative features, including anti-calcification technology[19]. - The company launched its sixth neurointerventional product, Yibida® guiding catheter, in the third quarter of 2020[19]. - The company plans to initiate clinical trials for the TaurusNXT® product in the second quarter of 2021[18]. - The company expects to complete the clinical trial recruitment for the TaurusElite® product by the third quarter of 2020[19]. Research and Development - Peijia Medical Limited is investing in R&D, allocating $DD million for the development of innovative medical technologies in 2020[7]. - The company has a research and development team of 51 employees focused on transcatheter valve therapy and neurointervention products, representing 14.5% of total full-time employees as of June 30, 2020[21]. - Research and development expenses rose to RMB 41,164 thousand for the six months ended June 30, 2020, compared to RMB 16,221 thousand in the previous year, reflecting an increase of 154%[91]. - Employee benefit expenses surged to RMB 46,896,000 for the six months ended June 30, 2020, compared to RMB 13,131,000 for the same period in 2019, marking an increase of 258%[93]. Strategic Acquisitions and Partnerships - Peijia Medical Limited is exploring strategic acquisitions to bolster its technological capabilities and market reach, aiming to complete at least one acquisition by the end of 2020[7]. - The company completed the acquisition of a competitor, which is expected to contribute an additional RMB 300 million in annual revenue starting next year[5]. - The company aims to expand its product portfolio through potential strategic acquisitions, investments, partnerships, and licensing opportunities[75]. Financial Position and Cash Management - Cash and cash equivalents totaled approximately RMB 2,595.6 million as of June 30, 2020, a 414.4% increase from approximately RMB 504.6 million as of December 31, 2019[31]. - The group had no borrowings as of June 30, 2020, and maintained a conservative cash management policy[32]. - The company has sufficient cash and financial resources to cover at least 125% of normal operating costs for the next 12 months despite the adverse impact of COVID-19[40]. - The company reported a significant increase in cash flow from financing activities, totaling RMB 2,377,071 thousand for the six months ended June 30, 2020, compared to RMB 1,111 thousand in the previous year[82]. Corporate Governance and Management - The board consists of three executive directors, four non-executive directors, and four independent non-executive directors, ensuring a high level of independence[42]. - The company is committed to maintaining high corporate governance standards and will continue to review its operations[42]. - The company has adopted the standard code for the trading of its securities by directors and senior management[43]. - The audit committee has reviewed the unaudited interim financial statements and believes the interim results comply with applicable accounting standards[45]. Share Options and Employee Incentives - The company has granted a total of 47,585,473 share options under the share option plan, which remain unexercised as of June 30, 2020[60]. - The share option plan allows for a maximum of 2,911,989 shares to be granted, representing approximately 12.7% of the total issued share capital prior to the global offering[55]. - The company has established an employee trust to manage the share option plan, with the trustee agreeing to act on the instructions of Dr. Zhang regarding voting rights[59]. - The stock option plan is designed to reward employees and directors for their contributions, with the expectation that it will lead to an increase in share price[68]. Regulatory Approvals and Compliance - The company anticipates regulatory approval for its new products from the National Medical Products Administration by the end of Q3 2021[5]. - The company is preparing to submit a registration application for TaurusOne® to the National Medical Products Administration for expedited regulatory review[24]. Market Conditions and Challenges - The revenue from neurointerventional products reached RMB 14.24 million during the reporting period, despite negative impacts from COVID-19[19]. - The gross margin for the six months ended June 30, 2020, decreased to 62.9% from 65.0% for the same period in 2019, mainly due to increased labor costs and raw material prices[27].