证券代码:300463 证券简称:迈克生物 公告编号:2024-086 迈克生物股份有限公司 关于部分募集资金专用账户注销完成的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性 陈述或者重大遗漏。 一、募集资金基本情况 经中国证券监督管理委员会《关于同意迈克生物股份有限公司向特定对象发行股票注册 的批复》（证监许可〔2021〕412号）的核准，迈克生物股份有限公司（以下简称"公司"）本 次向特定对象发行人民币普通股（A股）56,000,000股，每股发行价格为28.11元/股，募集资 金总额为人民币1,574,160,000.00元，扣除发行费用人民币（不含增值税）16,703,564.36 元，实际募集资金净额为人民币1,557,456,435.64元。 募集资金到位情况业经立信会计师事务所（特殊普通合伙）于2022年1月26日出具信会师 报字[2022]第ZD10018号《验资报告》审验。公司对募集资金采取专户存储制度。 二、募集资金存放与管理 为规范募集资金的管理，保护投资者利益，公司按照《深圳证券交易所创业板股票上市 规则》《上市公司自律监管指引第2号—创业板上市公司规 ...

证券代码:300463 证券简称:迈克生物 公告编号:2024-085 迈克生物股份有限公司 关于公司产品获得 IVDR CE 认证的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性 陈述或者重大遗漏。 近日，迈克生物股份有限公司（以下简称"公司"）6项化学发光试剂产品获得欧盟公告机 构BSI、南德TÜV SÜD签发的IVDR CE证书。具体获证情况如下： 根据欧盟体外诊断医疗器械法规的规定，上述取得IVDR CE证书的产品已经具备进入欧盟 市场的必要条件，有助于提升公司海外市场综合竞争力，对海外市场的拓展以及公司未来的经 营将产生积极影响。 | 产品名称 | 注册证 | 注册 | | | 注册证有效期 | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 书编号 | 类别 | | | | | | | | 总 IgE 测定试剂 | | | | | | | | 用于体外定量测定人血清或血浆 | | | IVDR | CE 认证 | 2024 | 年 3 | 月 | 28 | 日至 | | ...

| 项 目 | 工作内容 | | --- | --- | | 1.公司信息披露审阅情况 | | | （1）是否及时审阅公司信息披露文件 | 是 | | （2）未及时审阅公司信息披露文件的次数 | 不适用 | | 2．督导公司建立健全并有效执行规章制度的情况 | | | （1）是否督导公司建立健全规章制度（包括但不限于防 | | | 止关联方占用公司资源的制度、募集资金管理制度、内控 | 是 | | 制度、内部审计制度、关联交易制度） | | | （2）公司是否有效执行相关规章制度 | 是 | | 3.募集资金监督情况 | | | （1）查询公司募集资金专户次数 | 每月一次 | | （2）公司募集资金项目进展是否与信息披露文件一致 | 是 | | 4.公司治理督导情况 | | | （1）列席公司股东大会次数 | 无，均事前或事后审 | | | 阅会议议案 | | （2）列席公司董事会次数 | 无，均事前或事后审 | | | 阅会议议案 | 招商证券股份有限公司 关于迈克生物股份有限公司 2024 年半年度持续督导跟踪报告 | 保荐机构名称：招商证券股份有限公司 | 被保荐公司简称：迈克生物 | | --- | ...

迈克生物股份有限公司 证券代码:300463 证券简称:迈克生物 公告编号:2024-084 关于公司新产品取得产品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性 陈述或者重大遗漏。 迈克生物股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局颁发的《医疗 器械注册证（体外诊断试剂）》，具体情况如下： 二、对公司的影响 第 1 页 共 2 页 巨细胞病毒IgG抗体测定试剂盒（直接化学发光法），作为病原体抗体检测试剂，目前主 要用于巨细胞病毒感染的辅助诊断。单纯疱疹病毒2型IgM抗体检测试剂盒（直接化学发光法）， 作为病原体抗体检测试剂，目前主要用于单纯疱疹病毒2型感染的辅助诊断。前述产品均系公 司直接化学发光技术平台试剂新产品，配套公司全自动化学发光免疫分析仪i 6000、i 3000系 列、i 1000系列与i 800系列。截至目前公司在该技术平台下已累计取得111项试剂类产品注册 （涵盖甲状腺功能、传染病、心肌、肿瘤标志物、贫血、炎症、自身免疫性疾病、生殖激素、 骨代谢等病种检测）。新产品取得注册证进一步丰富了公司产品项目菜单，有助于提升公司市 特此公告 ...

证券研究报告 | 2024年08月11日 迈克生物（300463.SZ） 优于大市 单二季度归母净利同比增长 40%，自产试剂快速放量 单二季度归母净利润同比增长 40%，加快代理产品剥离及重塑自主产品经销 体系。2024 年上半年公司实现营收 12.79 亿（-7.37%），归母净利润 2.02 亿（+15.38%），扣非归母净利润 1.99 亿（+11.49%）；其中单二季度营收 6.63 亿（-5.93%），归母净利润 0.81 亿（+40.23%）。近两年公司加快代 理产品剥离以及重塑自主产品经销体系的调整速度，自主产品保持稳健增长 且收入占比提升较快，且自主产品成本优势远高于代理产品，自主产品销售 增长和结构提升将驱动业绩增长，自主产品净利润贡献由 2019 年 75.27%提 升至 87.24%。 自主产品试剂销量同比增长 23%，持续推进大型仪器及流水线的终端装机。 2024 年上半年自主产品收入 9.32 亿（+7.61%），毛利率为 72.42%（+1.54pp）； 其中自主产品试剂收入 8.59 亿（+5.9%），试剂销量同比增长 23.4%，收入 增速慢于销量的主要原因是受到了集采政策落 ...

2023042 公司点评报告 ·医药行业 24Q2 利润高速增长,流水线驱动未来成长 2024 年中报业绩点评 核心观点 ● 事件:公司发布 2024年半年度报告,2024年 1~6 月实现营业收入 12.79 亿 元（-7.37%），归母净利润 2.02 亿元（+15.38%），扣非净利润 1.99 亿元 (+11.49%),经营性现金流 2.13 亿元(-48.09%)。2024Q2 实现营业收入 6.63 亿元(-5.93%),归母净利润 0.81 亿元(+40.32%),扣非净利润 0.81 亿元(+39.45%),经营性现金流 2.08 亿元(-14.37%)。 ● 自主产品增长驱动业绩改善,代理产品业务进一步剥离:1自主产品:2024 年 1-6 月公司自主产品业务实现销售收入 9.32 亿元(+7.61%),收入占比已 由 2019年的 37.73%提升至 72.91% (+35.18pct)，净利润贡献已由 2019年 的 75.27%提升至 87.24%(+11.97pct); 2024H1 自主试剂产品销量同比增 长 23.4%,实现收入 8.59 亿元(+5.9%),毛利率 72.42% ...

Investment Rating - The report maintains a "Buy" rating for the company [4][5]. Core Views - The company continues to increase R&D investment and market promotion of its product lines, while also enhancing management efficiency and cost reduction, leading to stable performance and an increase in the proportion of self-developed products [2][4]. Financial Summary - For H1 2024, the company achieved operating revenue of 1.279 billion yuan (down 7.37%), net profit attributable to the parent company of 202 million yuan (up 15.38%), and non-recurring net profit of 199 million yuan (up 11.49%). Operating cash flow was 213 million yuan (down 48.09%) [4][5]. - The sales revenue of self-developed products in H1 2024 was 932 million yuan (up 7.61%), with a gross margin of 72.42% (up 1.54 percentage points). The sales revenue of agency products was 334 million yuan (down 32.69%), with a gross margin of 13.68% (down 7.75 percentage points) [4][5]. - The proportion of self-developed products in total revenue increased from 37.73% in 2019 to 72.91% in H1 2024, with their contribution to net profit rising from 75.27% in 2019 to 87.24% [4][5]. Product Development and Market Expansion - New products have been approved, and the promotion of automated testing lines is progressing smoothly, driving an increase in reagent sales. In H1 2024, the company achieved a shipment of 2,301 units of large instruments and testing lines, with reagent sales volume increasing by 23.4% year-on-year [4][5]. - The company is actively promoting the intelligent laboratory testing analysis pipeline and collaborating with various platform terminals, which is expected to lead to sustained growth in reagent sales [4][5]. Earnings Forecast - The report maintains EPS forecasts for 2024, 2025, and 2026 at 0.71 yuan, 0.86 yuan, and 1.05 yuan respectively, with a target price of 17.27 yuan, corresponding to a PE ratio of 24X for 2024 [4][5].

Investment Rating - The report maintains a "Buy" rating for the company [4][10]. Core Views - The company reported a revenue of 1.279 billion yuan in the first half of 2024, a year-on-year decline of 7.37%. However, the net profit attributable to shareholders increased by 15.38% to 202 million yuan, and the net profit after deducting non-recurring items grew by 11.49% to 199 million yuan [2][6]. - The decline in revenue is primarily due to the gradual divestment of agency business, which has put short-term pressure on performance. In contrast, revenue from self-produced reagents increased by 5.9% to 859 million yuan, with sales volume rising by 23.4% [7]. - The company has seen a significant increase in the installation of production lines, with 109 biological immune production lines and 110 blood production lines installed in the first half of 2024, which is expected to continue driving reagent sales [7][9]. - The gross profit margin improved to 57.00%, up by 3.62 percentage points, attributed to effective cost control. The net profit margin also increased to 15.83%, up by 3.39 percentage points [9]. - The company is focusing on research and development, with a slight increase in R&D expenses and marketing efforts. New products, including the i6000 chemiluminescence analyzer and C2000 fully automated biochemical analyzer, have been registered, enhancing the product matrix [9]. Financial Summary - The company expects revenues for 2024, 2025, and 2026 to be 3.007 billion, 3.321 billion, and 3.767 billion yuan, respectively, with year-on-year growth rates of 3.85%, 10.43%, and 13.44% [10]. - The net profit attributable to shareholders is projected to be 370 million, 494 million, and 680 million yuan for the same years, with growth rates of 18.36%, 33.49%, and 37.66% [10]. - Earnings per share (EPS) are expected to be 0.60, 0.81, and 1.11 yuan for 2024, 2025, and 2026, respectively [10].

证券代码:300463 证券简称:迈克生物 迈克生物股份有限公司 投资者关系活动记录表 | --- | --- | --- | --- | |------------|-----------------------|-------------|------------------| | | | | 编号：2024-IR003 | | | □特定对象调研 | ■分析师会议 | | | 投资者关系 | □媒体采访 □业绩说明会 | | | | 活动类别 | □新闻发布会 □路演活动 | | | | | □现场参观 | | | □其他（请文字说明其他活动内容） 华泰证券、国信证券、国联证券、国盛证券、东方证券、中信建投证券、中信 证券、中金公司、华安证券、华鑫证券、国投证券、野村证券、长江证券、银 河证券、太平洋证券、方正证券、申万宏源证券、国泰君安证券、建信养老金 参与单位名称 管理有限责任公司、东方证券资产管理有限公司、高毅资产、源峰基金、相聚 资本、长信基金、国盛资管、灏浚投资、众信资产、凯丰投资、北京弘道投 资、华强金控、APS 资产管理、康曼德资本共 32 家机构的 42 名参会人员。 时间 2024 年 ...

Investment Rating - The report maintains a "Recommended" rating for the company, indicating a positive outlook for its stock performance relative to the market [1]. Core Insights - The company reported a revenue of 1.279 billion yuan for the first half of 2024, a decrease of 7.37% year-on-year, while the net profit attributable to shareholders increased by 15.38% to 202 million yuan [1]. - The growth in self-developed products has driven performance improvement, with self-developed product sales reaching 932 million yuan, accounting for 72.91% of total revenue, up from 37.73% in 2019 [1]. - The company is actively advancing its laboratory automation solutions, which are expected to provide long-term growth momentum [1]. - Continuous investment in technological innovation is emphasized, with 25-30% of annual net profit allocated to R&D, totaling over 1.5 billion yuan in the last five years [1]. Financial Performance Summary - For the first half of 2024, the company achieved a gross profit margin of 57.00%, an increase of 3.62 percentage points year-on-year [1]. - The projected financial metrics for 2024-2026 include a net profit of 450.92 million yuan in 2024, representing a growth of 44.24% [5][9]. - The expected earnings per share (EPS) for 2024, 2025, and 2026 are 0.74 yuan, 0.92 yuan, and 1.14 yuan, respectively [5][9]. Strategic Focus - The company is focusing on enhancing its product portfolio and maintaining a comprehensive strategy across various platforms, including biochemical, immunological, and molecular diagnostics [1]. - The report highlights the importance of the company's automation solutions in driving the rapid growth of self-developed products [1].