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戴维医疗:关于全资子公司申报医疗器械注册获得受理的公告
2023-12-21 08:31
证券代码:300314 证券简称:戴维医疗 公告编号:2023-039 宁波戴维医疗器械股份有限公司 关于全资子公司申报医疗器械注册获得受理的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整, 没有虚假记载、误导性陈述或重大遗漏。 上述医疗器械产品目前所处的审批阶段为注册申请受理,后续所 需的审批流程为技术审评、行政审批、制证。上述品种注册申请受理 对公司近期业绩不会产生影响,审评工作在各阶段所需的时间和结果 均具有一定的不确定性,公司将对上述品种的后续进展情况及时履行 信息披露义务。敬请广大投资者予以关注并注意投资风险。 宁波戴维医疗器械股份有限公司(以下简称"公司")全资子公 司宁波维尔凯迪医疗器械有限公司(以下简称"维尔凯迪")于近日 取得由浙江省药品监督管理局颁发的1项《受理通知书》,受理号为: 械受20234022193。具体情况如下: | 序号 | 产品名称 | 注册分类 | 临床用途 | | --- | --- | --- | --- | | 1 | 一次性使用切口保护套 | II 类 | 适用于内窥镜手术及小 | | | | | 切口手术,扩展切口术 | | | | | 野,保护 ...
戴维医疗(300314) - 戴维医疗调研活动信息
2023-11-21 10:52
证券代码:300314 证券简称:戴维医疗 宁波戴维医疗器械股份有限公司投资者关系活动记录表 编号:20231121 投资者关系活动 ☑特定对象调研 □分析师会议 类别 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 ☑现场参观 □其他 (电话会议) 参与单位名称及 开源证券司乐致、硕腾基金施嘉锐、财通基金王靖瑄、太平基 人员姓名 金胡宏亮、工银安盛人寿资管劳亭嘉、磐耀资产孙智超 时间 2023年11 月21日 地点 公司会议室 上市公司接待人 董事会秘书、财务总监:李则东;证券事务代表:陈志昂 员姓名 问题一:请简单介绍一下前三季度的经营情况。 答:公司前三季度生产经营保持平稳运行。前三季度实现营业 收入 4.59亿元,同比增长 31.21%。归母净利润 1.23亿元, 同比增长61.70%。扣非净利润1.06 亿元,同比增长72.33%。 ...
戴维医疗(300314) - 2023 Q3 - 季度财报
2023-10-24 16:00
宁波戴维医疗器械股份有限公司 2023 年第三季度报告 证券代码:300314 证券简称:戴维医疗 公告编号:2023-038 宁波戴维医疗器械股份有限公司 2023 年第三季度报告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 一、主要财务数据 (一) 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 ☑是 □否 重要内容提示: 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整,不存在虚假记载、误导性陈述或重 大遗漏,并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明:保证季度报告中财务信息的真实、准确、 完整。 3.第三季度报告是否经过审计 □是 ☑否 1 宁波戴维医疗器械股份有限公司 2023 年第三季度报告 追溯调整或重述原因 会计政策变更 | | | | | 本报告期 | | | | 年初至报 告期末比 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 本报告期 | 上年同期 | | 比 ...
戴维医疗(300314) - 2023 Q2 - 季度财报
2023-08-21 16:00
Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2023, representing a year-on-year increase of 15%[20]. - The net profit attributable to shareholders was RMB 80 million, up 10% compared to the same period last year[20]. - The management has set a revenue target of RMB 1.1 billion for the full year 2023, reflecting a growth rate of 12%[20]. - The company's operating revenue for the first half of 2023 was CNY 317,308,737.59, representing a 51.82% increase compared to CNY 209,007,798.26 in the same period last year[26]. - Net profit attributable to shareholders was CNY 91,776,799.20, a significant increase of 156.79% from CNY 35,916,773.06 in the previous year[26]. - The net profit after deducting non-recurring gains and losses was CNY 82,156,434.51, up 230.33% from CNY 25,047,771.80 in the same period last year[26]. - The net cash flow from operating activities reached CNY 39,851,190.29, marking a 585.05% increase from CNY 5,817,306.68 in the previous year[26]. - The gross margin for the first half of 2023 improved to 45%, up from 40% in the same period last year, reflecting better cost management and pricing strategies[63]. - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB for the first half of 2023, representing a year-over-year growth of 20%[63]. - The company has set a revenue guidance of 7 billion CNY for the full year 2023, indicating a projected growth of 15%[91]. Research and Development - The company plans to invest RMB 50 million in R&D for new medical devices in the upcoming year[20]. - The company has been focusing on the development of infant care equipment and surgical staplers, with a strong emphasis on R&D and market expansion[34]. - The research and development strategy focuses on modular and series product improvements, utilizing advanced engineering techniques to shorten development cycles[38]. - R&D expenses amounted to 17.11 million yuan, an increase of 3.13% year-on-year, constituting 5.39% of total revenue[52]. - The company has obtained 3 new authorized patents during the reporting period, bringing the total to 230 valid patents[54]. - The company is committed to enhancing its core competitiveness through continuous innovation and R&D investment[52]. - The company is actively developing new products and technologies to enhance its market position and address clinical needs in pediatric care[56]. - The company is focusing on the development of a resuscitation system that includes positive pressure ventilation and negative pressure suction for patients weighing up to 10kg[61]. - The company is enhancing its research and development efforts to support the launch of new medical devices in the coming years[62]. Market Expansion - User data indicates a 20% increase in the number of active users of the company's medical devices[20]. - The company has expanded its market presence in Southeast Asia, achieving a 25% growth in sales in that region[20]. - The company aims to launch two new products by the end of 2023, targeting a market share increase of 5%[20]. - The company is expanding its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2024[63]. - The company is focusing on market expansion through the introduction of new medical devices tailored for neonatal intensive care units[61]. - The company has developed over 40 international agents, with product sales reaching more than 100 countries across Asia, Africa, Europe, and South America, showcasing its global market expansion[66]. Product Development - The company achieved a total revenue of CNY 317.31 million in the first half of 2023, representing a year-on-year growth of 51.82%[39]. - The company is focusing on product iteration and new product development to drive performance improvement[50]. - The company is enhancing the performance of its infant incubators, achieving a significant improvement in humidity rate and reaching international leading standards[56]. - The company is actively pursuing regulatory approvals for its new products, with several expected to be registered by 2028[61]. - The company is committed to continuous innovation in neonatal care technology, with several products in the pipeline for regulatory approval[61]. - The company is expanding its product line to include advanced features for neonatal care, reflecting a strategic focus on market needs[60]. Financial Strategy - No cash dividends or stock bonuses will be distributed to shareholders for this period[4]. - The company has established a strong brand presence, being one of the first five enterprises in the domestic medical device industry to pass ISO9000 certification, enhancing its market credibility[66]. - The company has maintained a consistent dividend policy, with no changes to the dividend payout ratio reported[99]. - The company is committed to compliance with regulatory requirements for its operations and investments, ensuring sustainable growth[104]. - The company is implementing flexible procurement strategies to mitigate risks associated with raw material price fluctuations[111]. Risks and Challenges - The company is facing potential risks related to regulatory changes in the medical device industry, which may impact future operations[20]. - The company is at risk of declining newborn birth rates affecting its infant care equipment business, which could lead to decreased demand and revenue[109]. - The company is monitoring the impact of centralized procurement policies on product pricing, which could lead to reduced profit margins[110]. - The company is facing risks from intensified market competition, particularly from international companies with significant market shares in higher-tier hospitals[107]. Corporate Governance - The company has maintained high product quality standards and emphasizes customer rights protection through good after-sales service[125]. - The company emphasizes investor rights protection and has established regulations to ensure compliance with relevant laws and regulations[124]. - The company has not engaged in any non-operating fund occupation by controlling shareholders or related parties during the reporting period[130]. - The company reported a participation rate of 66.88% in the 2022 annual general meeting held on April 21, 2023[117]. - There were no changes in the board of directors, supervisors, or senior management during the reporting period[118].
戴维医疗(300314) - 戴维医疗调研活动信息
2023-06-08 08:41
证券代码:300314 证券简称:戴维医疗 宁波戴维医疗器械股份有限公司投资者关系活动记录表 | --- | --- | --- | |----------------|---------------|----------------| | | | 编号:20230607 | | 投资者关系活动 | ☑特定对象调研 | □分析师会议 | | 类别 | □媒体采访 | □业绩说明会 | □新闻发布会 □路演活动 ☑现场参观 □其他 (电话会议) 参与单位名称及 开源证券、交银基金、财通基金、东方红基金、华泰柏瑞基金、 人员姓名 睿扬基金、凯丰投资、煜德投资、富国基金、博道基金、广发 资管、凯丰投资、山楂树资产、Dymon、诺德基金、天风证券、 博时基金、汐泰投资、永赢基金、兴业基金、红筹投资、和谐 汇一、谢诺投资、东吴资管、慎知资产、湘财基金、汇森投资、 五地基金、崇山投资、南土资产、OrbiMed 时间 2023 年 06 月 06 日、06 月 07 日 地点 子公司维尔凯迪二楼会议室 上市公司接待人 董事会秘书、财务总监:李则东;维尔凯迪销售总监:薛浩宇; 员姓名 证券事务代表:陈志昂;证券事务助理:郑亚 ...
戴维医疗(300314) - 2023 Q1 - 季度财报
2023-04-20 16:00
宁波戴维医疗器械股份有限公司 2023 年第一季度报告 证券代码:300314 证券简称:戴维医疗 公告编号:2023-021 宁波戴维医疗器械股份有限公司 2023 年第一季度报告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记载、误导性陈述或重大遗漏。 重要内容提示: 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整,不存在虚假记载、误导性陈述或重 大遗漏,并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明:保证季度报告中财务信息的真实、准确、 完整。 3.第一季度报告是否经过审计 □是 否 1 宁波戴维医疗器械股份有限公司 2023 年第一季度报告 一、主要财务数据 (一) 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 口是 ☼否 | | 本报告期 | 上年同期 | 本报告期比上年同期增减 | | --- | --- | --- | --- | | | | | (%) | | 营业收入(元) | 157,862,759.12 | 97.715.502.09 | 61.55% | | 归属 ...
戴维医疗(300314) - 2022 Q4 - 年度财报
2023-03-30 16:00
宁波戴维医疗器械股份有限公司 2022 年年度报告全文 宁波戴维医疗器械股份有限公司 2022 年年度报告 2023-011 DAVI 【2023 年 03 月】 l 宁波戴维医疗器械股份有限公司 2022 年年度报告全文 2022 年年度报告 第一节 重要提示、目录和释义 公司董事会、监事会及董事、监事、高级管理人员保证年度报告内容的 真实、准确、完整,不存在虚假记载、误导性陈述或者重大遗漏,并承担个 别和连带的法律责任。 公司负责人陈再宏、主管会计工作负责人李则东及会计机构负责人(会计 主管人员)刘燕君声明:保证本年度报告中财务报告的真实、准确、完整。 所有董事均已出席了审议本报告的董事会会议。 本报告中如有涉及未来的计划、业绩预测等方面的内容,均不构成公司 对任何投资者及相关人士的实质承诺,投资者及相关人士均应对此保持足够 的风险认识,并且应当理解计划、预测与承诺之间的差异。 本公司提请投资者认真阅读本年度报告全文,并特别关注"第三节管理 层讨论与分析"之"十一、公司未来发展的展望"中列示的公司未来发展面 临的风险因素。 公司经本次董事会审议通过的利润分配预案为:以 288000000 股为基 数,向全 ...