香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容 概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對 因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損 失承擔任何責任。 中 國 數 碼 信 息 有 限 公 司 （於香港註冊成立之有限公司） （股份代號：250） 截 至2022年12月31日 止 年 度 之 未 經 審 核 年 度 業 績 公 告 業績 中國數碼信息有限公司（「本公司」）之董事會（「董事會」）謹此宣佈本公司及 其附屬公司（「本集團」）截至2022年12月31日止年度之未經審核年度業績， 該 年 度 業 績 乃 基 於 本 公 司 之 未 經 審 核 綜 合 管 理 帳 目，連 同 截 至2021年12 月31日止年度之可比較未經審核數字。 根 據 本 公 告「審 閱 未 經 審 核 年 度 業 績」一 段 所 述 之 原 因，本 集 團 截 至2021 年12月31日 止 年 度 之 年 度 業 績 的 審 核 程 序 尚 未 完 成 及 截 至2022年12月31 日止年度之年度業績審核程序尚未開始，本公司無法根據香港聯合交易 所有限公司證券上市規則（ ...

杭州啓明醫療器械股份有限公司 Venus Medtech (Hangzhou) Inc. （於中華人民共和國註冊成立的股份有限公司) 股份代號：2500 2022 中期報告 目錄 2 公司資料 4 財務摘要 5 管理層討論與分析 28 企業管治及其他資料 45 中期簡明綜合損益及其他全面收益表 47 中期簡明綜合財務狀況表 49 中期簡明綜合權益變動表 51 中期簡明綜合現金流量表 54 中期簡明綜合財務資料附註 82 釋 義 公司資料 （截 至 二 零 二 二 年 六 月 三 十 日） | 中文名稱： | 杭州啓明醫療器械股份有限公司 | | --- | --- | | 英文名稱： | Venus Medtech （Hangzhou） Inc. | | 法定代表： | 曾敏先生 | | 董事長： | 曾敏先生 | | 註冊資本： | 人民幣441,011,443元 | | 中國總部： | | | 註冊辦事處地址： | 中國杭州濱江區江陵路88號2幢3樓311室 | | 公司網址： | http://www.venusmedtech.com/ | | 電郵： | inquiry@venusmedtech.co ...

Financial Performance - Revenue for the six months ended June 30, 2022, was HK$507,552,000, representing a 14% increase from HK$445,208,000 in the same period of 2021[6] - Gross profit increased to HK$425,221,000, up 20% from HK$354,501,000 year-over-year[6] - Profit attributable to owners of the Company for the period was HK$7,208,000, compared to a loss of HK$35,013,000 in the previous year[10] - Basic and diluted earnings per share for the period were HK$0.04, a recovery from a loss of HK$0.18 per share in the same period last year[6] - Total comprehensive income for the period was a loss of HK$6,391,000, an improvement from a loss of HK$35,854,000 in the prior year[10] - The total comprehensive income for the period was a loss of HK$6,391,000, compared to a loss of HK$35,854,000 for the same period in 2021, indicating a 82.2% improvement[26] - The profit for the period was HK$7,208,000, a positive shift from a loss of HK$35,013,000 in the same period of 2021[21] - Other operating income increased to HK$80,276,000 from HK$64,547,000, marking a growth of about 24% year-over-year[61] - The reportable segment loss before income tax improved to HK$45,358,000 from HK$75,863,000, reflecting a reduction in losses of approximately 40%[54] - The revenue from the digital business and information technology services segment was approximately HK$35.7 million, with a loss before income tax of approximately HK$28.1 million during the reporting period[128] Assets and Liabilities - Non-current assets decreased to HK$2,248,953,000 from HK$2,222,473,000 as of December 31, 2021[13] - Current liabilities totaled HK$916,589,000, down from HK$955,285,000 at the end of 2021[15] - Net assets increased to HK$1,520,293,000 from HK$1,456,943,000 as of December 31, 2021[15] - The Group reported net current liabilities of approximately HK$651,500,000 as of June 30, 2022[40] - Reportable segment assets as of June 30, 2022, totaled HK$1,247,414,000, down from HK$1,320,473,000 as of December 31, 2021, representing a decrease of about 5.5%[56] - Reportable segment liabilities decreased to HK$747,584,000 from HK$778,463,000, indicating a reduction of approximately 4%[56] Cash Flow - For the six months ended June 30, 2022, the net cash used in operating activities was HK$7,567,000, a significant improvement compared to HK$99,147,000 for the same period in 2021, representing an 92.4% decrease[18] - The net cash used in investing activities was HK$6,771,000, a decline from the cash generated of HK$182,517,000 in the previous year[18] - The net cash used in financing activities was HK$27,084,000, compared to cash generated of HK$65,345,000 in the prior year[18] - Cash and cash equivalents decreased to HK$48,681,000 at June 30, 2022, down from HK$416,039,000 at the beginning of the year, marking an 88.3% decline[18] - The Group's cash and cash equivalents were approximately HK$48.7 million as of June 30, 2022, down from approximately HK$92.7 million as of December 31, 2021[134] Segment Performance - For the six months ended June 30, 2022, the total revenue from reportable segments was HK$507,552,000, representing an increase of 14% compared to HK$445,208,000 in the same period of 2021[54] - Revenue from enterprise cloud services was HK$471,816,000, up from HK$445,208,000, indicating a growth of 6% year-over-year[58] - The digital business and information technology services segment generated revenue of HK$35,736,000, which was a new addition as there was no revenue reported in the same period last year[58] Employee and Management - The Group's total employee salaries and allowances for the six months ended June 30, 2022, were approximately HK$363.6 million, compared to approximately HK$359.4 million for the same period in 2021, reflecting a slight increase of 0.6%[142] - As of June 30, 2022, the Group employed approximately 4,351 employees, a decrease from 5,531 employees as of June 30, 2021, indicating a reduction of about 21.4%[142] - The Group focuses on providing skill and quality training for employees, emphasizing on-the-job capability training and personal work attitude[142] - The Group's employee remuneration policy includes basic salary, housing benefits, and contributions to mandatory provident funds, among other benefits[142] Corporate Governance and Compliance - The company has complied with the Corporate Governance Code throughout the six months ended June 30, 2022, except for delays in issuing audited annual results and convening the annual general meeting[176][180] - The Company has adopted the Model Code for Securities Transactions by Directors and confirmed compliance by all directors for the six months ended June 30, 2022[192] - Trading in the Company's shares on the Hong Kong Stock Exchange has been suspended since April 1, 2022, pending fulfillment of Resumption Guidance[200] Share Capital and Dividends - The company did not declare or pay any dividends during the six months ended June 30, 2022, consistent with the same period in 2021[72] - The company maintained the same number of issued and fully paid ordinary shares at 21,720,504,877 as of June 30, 2022, with a share capital of HK$240,597,000[86] - The Company’s share option scheme lapsed on May 28, 2022, indicating a shift in employee incentive strategies[142] Loans and Financial Obligations - As of June 30, 2022, the outstanding principal and accrued interests of the loan to Nan Hai are approximately HK$758,996,000 and HK$60,886,000 respectively, with an interest rate of 8% per annum[184][186] - The Digital Huigu Loan is subject to an interest rate of 8% per annum, with a default interest rate of 10% per annum on any overdue amounts[190] - The repayment due date for the Digital Huigu Loan has been extended to June 20, 2024, following a supplemental agreement made on April 7, 2021[190] Market and Product Development - CE Dongli launched the 2022 global portal foreign trade professional edition, which supports 42 languages and has achieved industry-leading performance in Google search engine optimization[124] - The new global portal marketing professional edition features enhanced automatic website optimization capabilities, significantly improving digital marketing automation for clients[123] - The loading speed of clients' websites using the new foreign trade edition is more than double that of top competitors in the industry, ensuring better performance[124] - The Group has established a nationwide localized service network to effectively address the "last kilometer" issue in delivering SaaS solutions to corporate clients[110] - CE Dongli's digital marketing products cater to a wide range of clients, from large enterprises to small and micro-sized businesses, demonstrating a complete product spectrum[118]

Company Overview and Strategy - The company has implanted over 9,000 TAVR products since their launch, with VenusA-Valve being the only product in China with 9 years of follow-up data[10]. - In January 2022, the company completed the acquisition of Cardiovalve, which focuses on innovative therapies for mitral and tricuspid valve diseases, indicating significant market potential[11]. - The company aims to enhance its international brand influence through the commercialization of VenusP-Valve in the EU[11]. - The company is committed to high-quality innovation and strategic planning to improve its competitiveness in the medical device industry[13]. - The company emphasizes the importance of innovation and internationalization in response to the challenges faced in the medical industry[9]. - The company is recognized as a leading enterprise in the field of minimally invasive treatment for structural heart disease in China[10]. - The company is focused on developing and commercializing innovative medical devices for structural heart disease[10]. - The company anticipates achieving strategic milestones to benefit more patients globally[11]. - The company has established a comprehensive solution for structural heart disease, covering various heart valve diseases and related procedures[10]. Financial Performance - Revenue for 2021 reached RMB 415,862 thousand, a significant increase of 50.7% compared to RMB 276,047 thousand in 2020[15]. - Gross profit for 2021 was RMB 324,344 thousand, up 42.7% from RMB 227,280 thousand in 2020[15]. - The company reported a pre-tax loss of RMB 377,555 thousand in 2021, worsening from a loss of RMB 185,843 thousand in 2020[15]. - Total non-current assets increased to RMB 1,669,835 thousand in 2021, compared to RMB 957,794 thousand in 2020, reflecting a growth of 74.3%[17]. - Current assets totaled RMB 3,439,622 thousand in 2021, slightly up from RMB 3,360,433 thousand in 2020[17]. - VenusA-Valve and VenusA-Plus generated sales revenue of RMB 405.3 million for the year ending December 31, 2021, representing a 49% increase from RMB 272.0 million for the year ending December 31, 2020[29]. - The company's total revenue for the year ended December 31, 2021, was approximately RMB 415.9 million, an increase of 50.7% compared to RMB 276.0 million for the year ended December 31, 2020[78]. - Sales from VenusA-Valve and VenusA-Plus accounted for 97.4% of total revenue, generating RMB 405.3 million, compared to 98.5% in the previous year[81]. Product Development and Innovation - The company has established a product pipeline consisting of 14 innovative devices, including two marketed TAVR products, VenusA-Valve and VenusA-Plus[21]. - The company is focusing on developing new materials, biomimetics, imaging integration technology, and digital sensing to enhance its product offerings[19]. - VenusP-Valve has completed clinical trials in both the European Union and China, with CE mark certification expected in 2022[31]. - Long-term clinical studies for VenusP-Valve demonstrated a 100% procedural success rate and a 5-year postoperative mortality rate of only 3.64%[34]. - Venus-PowerX, a new generation TAVR product, completed its first-in-man clinical trial on December 21, 2021[37]. - Venus-Vitae, another new generation TAVR system, successfully completed its first two FIM clinical implants in Argentina on December 16, 2021[41]. - The company emphasizes that it may not ultimately succeed in developing and marketing VenusA-Valve, VenusA-Plus, VenusP-Valve, Venus-PowerX, and Venus-Vitae[30][36][40][42]. Acquisitions and Partnerships - Cardiovalve acquisition completed for $266 million, with milestone-based conditional payments[44]. - The company plans to accelerate clinical development and registration in the Chinese market post-Cardiovalve acquisition[46]. - Liwen RF acquisition for a maximum price of RMB 493 million, aimed at enhancing treatment options for HCM patients[56]. - The company has signed a strategic cooperation framework agreement with United Family Healthcare to establish treatment collaboration for VenusA-Valve and VenusA-Plus, enhancing patient care for heart valve diseases[28]. - The company actively collaborates with leading innovative medical device companies and academic institutions to enhance its product pipeline and maintain a competitive edge in structural heart disease technology[62]. - The company has established the Venus Global Heart Valve Innovation Center in Israel to focus on breakthrough innovative therapeutic technologies, including the development of next-generation aortic regurgitation treatment technologies[63]. Research and Development - The company's R&D expenses were RMB 167.3 million and RMB 258.3 million for the years ended December 31, 2020, and December 31, 2021, respectively, indicating a year-over-year increase of 54.3%[64]. - As of February 28, 2022, the company held a total of 756 patents and patent applications, including 315 granted invention patents, with 284 applications in China and 445 overseas[65]. - The company has made significant contributions to the clinical trials and registration of TMVR and TPVR products, such as VenusA-Valve and VenusP-Valve[160]. Risk Factors - The company has identified several key risks, including those related to product development, government regulations, commercialization, production, and reliance on third parties[129]. - The company has incurred net losses since its establishment and may continue to do so in the foreseeable future, posing a high risk to potential investors[130]. - Future growth is largely dependent on the success of product development; significant delays in clinical development or regulatory approval could severely impact the business[130]. - The clinical product development process is lengthy and costly, with uncertain outcomes; failures in clinical trials could have a major adverse effect on future prospects[132]. - Regulatory approvals are critical for commercialization; delays or failures in obtaining necessary approvals could severely impair revenue generation capabilities[132]. - The company faces significant competition, which may lead to others successfully developing or commercializing competitive products before it does[134]. - The company relies on a limited number of suppliers; any loss of qualification or contractual disputes could severely damage operations[137]. - The company’s goodwill constitutes a significant portion of its total assets, and any impairment could adversely affect its financial condition[143]. Governance and Management - The company has a strong governance structure with independent directors providing oversight on major decisions and management performance[182]. - The company emphasizes compliance with listing rules and corporate governance standards in its operations[184]. - The company is focused on maintaining financial oversight and monitoring the performance of its directors and senior management[186]. - The company is committed to maintaining high standards of financial management and oversight through its appointed executives[198].

Financial Performance - The company reported a total revenue of HKD 1,016,061,000 for the year ended December 31, 2021, representing an increase from HKD 972,139,000 in 2020, which is approximately a 4.5% growth[5]. - The gross profit for the year was HKD 822,916,000, slightly up from HKD 818,151,000 in the previous year, indicating a stable gross margin[5]. - The company incurred a net loss attributable to shareholders of HKD 107,960,000 for the year, compared to a profit of HKD 111,014,000 in 2020, reflecting a significant decline in profitability[5]. - Operating expenses increased to HKD 715,690,000 from HKD 526,526,000, marking a rise of approximately 36% year-over-year[5]. - The company reported other operating income of HKD 127,073,000, down from HKD 135,024,000 in the previous year, indicating a decrease of about 5.3%[5]. - The company’s comprehensive loss for the year was HKD 101,781,000, compared to a comprehensive income of HKD 115,344,000 in 2020, indicating a shift in overall financial performance[7]. - The company’s basic and diluted loss per share was HKD 0.54, a decline from earnings per share of HKD 0.56 in the previous year[5]. - The foreign exchange gain from overseas operations was HKD 5,759,000, up from HKD 3,541,000, reflecting improved currency management[7]. Assets and Liabilities - Total assets decreased from HKD 1,589,369,000 in 2020 to HKD 1,544,064,000 in 2021, representing a decline of approximately 2.8%[9]. - The company's total liabilities increased from HKD 688,932,000 in 2020 to HKD 955,285,000 in 2021, indicating a rise of about 38.7%[10]. - The net asset value decreased from HKD 1,556,589,000 in 2020 to HKD 1,456,943,000 in 2021, reflecting a reduction of approximately 6.4%[10]. - The company's equity decreased from HKD 1,315,992,000 in 2020 to HKD 1,216,346,000 in 2021, a decline of about 7.5%[10]. - The company reported a cash and cash equivalents balance of HKD 92,698,000 in 2021, down from HKD 265,080,000 in 2020, a decrease of approximately 65%[9]. - The company’s total liabilities to total assets ratio increased from approximately 43.3% in 2020 to 61.8% in 2021, indicating a higher leverage position[10]. - The company’s retained earnings decreased from HKD 1,315,992,000 in 2020 to HKD 1,216,346,000 in 2021, a decline of about 7.5%[10]. - The company reported a significant increase in deferred tax liabilities from HKD 2,771,000 in 2020 to HKD 57,522,000 in 2021, reflecting a rise of approximately 1940%[10]. Revenue Segments - Revenue from bundled services was HKD 732,781,000 in 2021, down from HKD 809,961,000 in 2020, indicating a decline of about 9.5%[23]. - Internet infrastructure services revenue increased significantly to HKD 161,376,000 in 2021 from HKD 78,086,000 in 2020, marking a growth of approximately 106.5%[23]. - The total revenue from external customers for the "Enterprise Cloud Services" segment in 2021 was HKD 972,008,000, compared to HKD 972,139,000 in 2020, indicating a slight decrease of 0.01%[28]. - The "Digital Business and Information Technology Services" segment reported no revenue in 2021, while the total revenue for the reportable segments was HKD 1,038,798,000 in 2021, up from HKD 972,139,000 in 2020, reflecting an increase of 6.8%[28]. Acquisitions and Investments - The company completed the acquisition of 100% equity in Digital Star Technology Development (Beijing) Co., Ltd. for RMB 488 million (approximately HKD 585.9 million) on July 26, 2021[46]. - The company completed the acquisition of Chenxing Technology Group on July 26, 2021, enhancing its digital commerce and information technology services[54]. - The goodwill recognized from the acquisition was HKD 323,247,000[50]. - The acquisition of Chenxing Technology was completed on July 26, 2021, for a price of RMB 488 million, which will be consolidated into the company's financial statements[67]. Future Outlook and Strategy - The company anticipates generating positive operating cash flow in 2022, ensuring sufficient resources to meet its working capital and other financing needs[16]. - The company expects that the new amendments to the Hong Kong Financial Reporting Standards will not have a significant impact on its consolidated financial performance[22]. - The company anticipates continued growth in enterprise cloud services and ticket management system services in the upcoming fiscal year[24]. - The company has plans for market expansion and new product development to enhance its service offerings[23]. - The company is focused on improving operational efficiency and exploring potential mergers and acquisitions to drive future growth[23]. - The company is actively monitoring RMB exchange rate fluctuations, which may impact its financial performance, and has not entered into any foreign exchange hedging instruments during the year[75]. - Overall, the company remains optimistic about future growth, citing strong demand and a robust pipeline of products and services[91]. Employee and Governance - As of December 31, 2021, the company had 4,891 employees, a decrease from 5,418 employees in 2020[76]. - Total employee compensation and benefits amounted to approximately HKD 746.4 million for the year ended December 31, 2021, compared to approximately HKD 567.5 million in 2020, representing an increase of 31.5%[76]. - The company has adhered to applicable corporate governance codes throughout the year ended December 31, 2021, with minor deviations noted[80]. - The audit committee consists of all independent non-executive directors, ensuring oversight of the financial reporting process[82]. Financial Reporting and Compliance - The company is currently undergoing a review process for its annual performance, which has not yet been completed, delaying the publication of the audited financial results[3]. - The financial statements are prepared based on the Hong Kong Financial Reporting Standards, which include applicable individual standards and interpretations[14]. - The company plans to issue its annual report by April 30, 2022, which will include all information required by the listing rules[89]. - The company expects no significant deviation between the unaudited financial results and the audited results for the year ended December 31, 2021[86].

杭州啓明醫療器械股份有限公司 Venus Medtech (Hangzhou) Inc. （於中華人民共和國註冊成立的股份有限公司) 股份代號：2500 2021 中期報告 目錄 2 公司資料 4 財 務 摘 要 5 管理層討論與分析 27 企業管治 及 其他資料 41 中期簡明綜合損益及其他全面收益表 43 中期簡明綜合財務狀況表 45 中期簡明綜合權益變動表 47 中期簡明綜合現金流量表 50 中期簡明綜合財務資料附註 68 釋 義 公司資料 （截至二零二一年六月三十日） | 中文名稱： | 杭州啓明醫療器械股份有限公司 | | --- | --- | | 英文名稱： | Venus Medtech (Hangzhou) Inc. | | 法定代表： | 曾敏先生 | | 董事長： | 曾敏先生 | | 註冊資本： | 人民幣441,011,443元 | | 中國總部： | | | 註 冊 辦事處地址： | 中國杭州濱江區江陵路88號2幢3樓311室 | | 公司網址： | http://www.venusmedtech.com/ | | 電 郵： | inquiry@venusmedtech.com | ...

Financial Performance - The company's total revenue for the year reached RMB 276 million, representing an 18.3% year-over-year growth, with a 38.3% increase in the second half of the year[5]. - In 2020, the company's revenue reached RMB 276,047,000, a 18.3% increase from RMB 233,272,000 in 2019[13]. - Gross profit for 2020 was RMB 227,280,000, up 16.7% from RMB 194,665,000 in 2019[13]. - The company reported a pre-tax loss of RMB 185,843,000 in 2020, an improvement from a loss of RMB 381,543,000 in 2019[13]. - Other income and gains rose significantly by 667.5% to RMB 118.2 million, attributed to increased government project subsidies and higher interest income from bank deposits[58]. - The adjusted net loss for the year ended December 31, 2020, was RMB 173.868 million, a decrease from RMB 235.473 million in 2019, representing a 26.2% improvement[69]. - Cash and cash equivalents as of December 31, 2020, amounted to RMB 2,708.2 million, an increase of 12.2% from RMB 2,413.3 million as of December 31, 2019[71]. - The company had no borrowings as of December 31, 2020, a reduction of 100% from RMB 120.0 million in borrowings as of December 31, 2019[72]. Product Development and Innovation - The second-generation artificial valve system, VenusA-Plus, received approval from the National Medical Products Administration in November 2020, becoming China's first artificial valve system with a recapturable feature[6]. - The self-expanding pulmonary valve product, VenusP-Valve, is in the final stage of CE certification in Europe and is preparing for clinical registration in the United States[10]. - The company has two TAVR products already on the market and several others in various stages of development, including one in the pre-registration phase[19]. - VenusA-Plus, an upgraded product based on VenusA-Valve, received NMPA approval in November 2020 and is the first recyclable TAVR product approved in China[28]. - The company is developing VenusA-Pro Valve, which aims to improve control over valve deployment and recoverability, with preclinical studies ongoing[33]. - Venus PowerX Valve is in the design phase with animal studies being conducted, focusing on features like coronary access and recoverability[34]. - Venus Vitae Valve is also under development, utilizing balloon-expandable technology for severe aortic stenosis treatment, with ongoing animal studies[37]. Market Expansion and Strategic Partnerships - The company is actively seeking strategic partnerships globally, including collaborations with Opus Medical Therapies, LLC and Pi-Cardia Ltd. for innovative device development[9]. - The company aims to expand its global presence and promote its brand internationally, leveraging its academic expertise and business capabilities[11]. - The company plans to commercialize VenusP-Valve and other products in China, leveraging its experience from the successful commercialization of VenusA-Valve[93]. - The company plans to leverage existing brands like TriGUARD3 to enter the US and EU markets, with clinical trials and registrations ongoing[97]. - The company is considering strategic acquisitions to enhance its product offerings and market presence[160]. Risk Management and Compliance - The company faces significant risks related to product development, regulatory approvals, and potential delays in commercialization[101]. - Regulatory compliance is critical, as failure to obtain necessary approvals could severely impact the company's ability to commercialize products[104]. - The company recognizes the importance of risk management and has adopted a comprehensive risk management policy to identify and mitigate key risks[119]. - The company has established a dedicated intellectual property department to assist in the registration and analysis of intellectual property rights[126]. - The management team is committed to ensuring compliance with legal regulations to mitigate potential liabilities related to intellectual property[125]. Sales and Marketing Strategies - The internal sales team focuses on academic marketing to promote TAVR products and increase market penetration in China[51]. - The company employs a strategic marketing model to promote and sell its products through partnerships with hospitals and training relationships, focusing on major tertiary hospitals[186]. - The company actively participates in significant cardiology conferences in China, providing training on TAVR and TPVR procedures, showcasing product innovations and advantages[189]. - The company relies on opinion leaders to introduce and recommend its products to physicians and hospitals, enhancing product awareness through direct education and training[190]. Future Outlook and Guidance - The company provided guidance for the next fiscal year, projecting revenue growth of 25% and aiming to reach 1.875 billion[151]. - New product launches are expected to contribute an additional 300 million in revenue, with a focus on innovative medical devices[151]. - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by the end of the next fiscal year[151]. - Future guidance indicates a focus on sustainability initiatives, aiming for a J% reduction in carbon footprint by the end of the fiscal year[160].

目錄 2 公司資料 3 財 務 摘 要 68 釋 義 2020年中期報告 2 公司資料 （截至二零二零年六月三十日） 財務摘要 | | 截 至 | 截 至 | | | --- | --- | --- | --- | | | 二零二零年 | 二零一九年 | | | | 六月三十日 | 六月三十日 | | | | 止六個月 | 止六個月 | 同比變動 | | | （未 經 審 核） | （未經審核） | | | | 人民幣千元 | 人民幣千元 | | | 收 入 | 102,049 | 107,423 | (5%) | | 毛 利 | 85,087 | 88,447 | (4%) | | 除稅前虧損 | (43,529) | (185,770) | (77%) | | 期內虧損 | (43,538) | (185,782) | (77%) | | 母公司擁有人應佔虧損 | (43,524) | (185,762) | (77%) | | 母公司普通股權持有人應佔每股虧損 | | | | | 基本及攤薄 （人民幣元） | (0.11) | (0.62) | (82%) | 3 杭州啓明醫療器械股份有限公司 管理層討 ...

Financial Performance - In 2019, the company generated revenue of RMB 233.3 million, a 102.4% increase from RMB 115.3 million in 2018[9] - The gross profit for 2019 was RMB 194.7 million, compared to RMB 99.0 million in 2018, reflecting a significant growth in profitability[9] - The company reported a pre-tax loss of RMB 381.5 million in 2019, an increase from RMB 299.6 million in 2018[9] - For the year ended December 31, 2019, the company's total revenue was RMB 233.3 million, an increase of 102.3% compared to RMB 115.3 million for the year ended December 31, 2018[43] - VenusA-Valve accounted for 99.5% of total revenue for the year ended December 31, 2019, up from 98.6% for the year ended December 31, 2018[43] - Gross profit increased by 96.7% to RMB 194.7 million for the year ended December 31, 2019, from RMB 99.0 million for the year ended December 31, 2018, while the gross margin decreased from 85.8% to 83.5% due to a slight decline in average selling prices[47] - Other income and gains for the year ended December 31, 2019, amounted to RMB 15.4 million, a 16.7% increase from RMB 13.2 million for the year ended December 31, 2018[48] - Selling and distribution expenses for the year ended December 31, 2019, were RMB 124.6 million, an increase of 86.2% from RMB 66.9 million for the year ended December 31, 2018, driven by increased market development expenses and sales personnel costs[50] - Research and development costs for the year ended December 31, 2019, were RMB 200.5 million, a 91.3% increase from RMB 104.8 million for the year ended December 31, 2018, primarily due to the consolidation of Keystone's financial statements after its acquisition[51] - Administrative expenses for the year ended December 31, 2019, were RMB 197.6 million, a decrease of 11.7% from RMB 223.9 million for the year ended December 31, 2018, mainly due to a significant share-based payment in 2018[53] - The adjusted net loss for the year ended December 31, 2019, was RMB 235.5 million, compared to RMB 54.7 million for the year ended December 31, 2018, indicating a significant increase in losses[60] Product Development and Market Strategy - The VenusA-Valve product generated sales revenue of RMB 232.1 million in 2019, marking a substantial increase in market penetration[5] - The company is currently conducting clinical trials for the VenusP-Valve in the US and EU, with plans to apply for NMPA approval and CE certification[5] - The company focuses on the rapidly growing transcatheter heart valve market, with a product pipeline that includes six self-developed products[10] - VenusA-Plus, an upgraded product based on VenusA-Valve, is expected to be the first recoverable TAVR product in China once launched[21] - The company is designing the Venus Mitral Valve for TMVR treatment and is currently in the design stage of animal studies[31] - The Venus Tricuspid Valve is also in the design stage of animal studies, with plans to submit clinical trial results for NMPA approval[32] - The company plans to commercialize VenusP-Valve and other products in China, leveraging the experience gained from the successful commercialization of VenusA-Valve[88] - The company aims to expand its market share in North America and the EU, benefiting from higher healthcare expenditure levels in these regions compared to China[89] - Clinical trials and registration applications are ongoing in the US, EU, and emerging markets, with plans to utilize existing brands like TAV8 and TriGUARD3 for market entry[92] - The company plans to enhance its product pipeline in structural heart disease, covering all four heart valves and investing in technological innovation[94] Financial Position and Capital Management - Total non-current assets reached RMB 764.4 million as of December 31, 2019, compared to RMB 743.7 million in 2018[9] - The total equity of the company increased to RMB 3,045.7 million in 2019, up from RMB 470.4 million in 2018[9] - Cash and cash equivalents as of December 31, 2019, amounted to RMB 2,413.3 million, representing a 1,363.5% increase from RMB 164.9 million as of December 31, 2018, primarily due to proceeds from the initial public offering[62] - Total borrowings, including interest-bearing loans, increased by 50% to RMB 120 million as of December 31, 2019, compared to RMB 80 million as of December 31, 2018, mainly due to increased bank loans[64] - The capital debt ratio decreased by 77.7% to 4.8% as of December 31, 2019, from 21.5% as of December 31, 2018, indicating improved financial stability[64] - The net value of current assets as of December 31, 2019, was RMB 2,336.0 million, a change of 1,236.7% compared to the net current liabilities of RMB 205.5 million as of December 31, 2018[65] - The company relies on shareholder capital contributions and bank loans as primary sources of working capital, with expectations of increased cash flow from existing commercialized products and new product launches[63] Risks and Challenges - The company acknowledges the uncertainty in successfully marketing VenusA-Valve in Brazil and Taiwan[18] - The company faces significant risks related to regulatory approvals for product commercialization, which could severely impact revenue generation capabilities[100] - Recent and future legislation may increase the difficulty and cost of obtaining regulatory approvals for the company's products[100] - The company's reputation, revenue, and profitability could be adversely affected if its products are associated with serious adverse events[102] - The company may experience significant adverse effects from fluctuations in raw material prices[105] - The inability to maintain inventory levels in line with product demand could lead to sales losses or excess inventory risks[105] - The company may face challenges in protecting its intellectual property, which could allow third parties to compete directly[105] - Legal disputes related to intellectual property could incur high costs and delay product development or commercialization[105] - The company relies on strong relationships with key doctors and leading hospitals for clinical development and marketing[108] - The company has faced risks related to government grants for R&D activities, with uncertainty about future funding availability[110] Governance and Management - The company has a strong governance structure with experienced directors and advisors contributing to its strategic direction[143] - The board proposed a restricted stock incentive plan to improve corporate governance and motivate key employees, pending shareholder approval[77] - The audit committee oversees the implementation of risk management policies and ensures alignment with corporate objectives[118] - The Chief Financial Officer is responsible for formulating and updating risk management policies and measures, as well as reviewing major risk management issues[118] - The company has appointed independent directors with significant experience in corporate governance and healthcare investments[139] Market Trends and Future Outlook - The global market for TAVR procedures is expected to grow as more patients become eligible for TAVR surgery, particularly in China and the Philippines[16] - The demand for VenusP-Valve is anticipated to increase due to the rising number of patients with congenital heart defects and the potential for government insurance coverage[27] - The company believes the impact of COVID-19 will be temporary and remains committed to being a global leader in the development and commercialization of structural heart disease solutions[76] - The company plans to increase sales of the VenusA-Valve significantly to strengthen its leading position in the Chinese TAVR market[84] - There is a substantial unmet demand for TAVR products among hospitals currently selling VenusA-Valve, indicating potential for market expansion[85] - The company aims to enhance awareness of TAVR among structural heart disease patients, particularly low surgical risk patients, to expand the patient base for TAVR products[87] Research and Development - The company has established a strong R&D, manufacturing, and commercialization capability in its transcatheter heart valve platform[37] - The company has a strong emphasis on research and development, particularly in the field of minimally invasive heart valve and medical device solutions[131] - The management team has extensive industry experience, with key members having held senior positions in other medical technology companies[131] - The company is focused on innovative minimally invasive surgical techniques, as indicated by Mr. Liu's involvement with a company specializing in this area[148] Marketing and Sales Strategy - The company employs a strategic marketing model to promote and sell its products through partnerships with hospitals and training relationships, focusing on major tertiary hospitals[181] - The company actively participates in significant cardiology conferences in China, providing training on TAVR and TPVR procedures, showcasing product innovations and advantages[184] - The company relies on opinion leaders to introduce and recommend its products to physicians and hospitals, enhancing product awareness through direct education and training[185] - The company has established a skilled sales and marketing team that focuses on educating and training physicians on the use of its products through regular visits and demonstrations[185]