甘李药业（603087.SH）2023年年报&2024年一季报点评 集采加速三代胰岛素放量，出海打开成长天花板 2024年04月26日 ➢ 产品销量迅速增长，2023年实现扭亏为盈。2024年4月24日，公司发布 推荐 维持评级 2023年年报，2023年公司实现营业收入为26.08亿元，同比增长52.31%；归 当前价格： 48.77元 母净利润为3.40亿元，较上年同期相比，实现扭亏为盈。同日公司发布2024年 一季报，2024年一季度公司实现营业收入5.60亿元，较上年同期增长0.42%； [Table_Author] 实现归母净利润9600万元，同比增长95.04%。 ➢ 集采加速国产替代，公司产品实现快速放量。2023 年，公司国内销售收入 达21.82亿元，同比增长51.93%。国内制剂产品销量同比增长66.36%，其中， 基础胰岛素产品销售量同比增长 32.47%，餐时和预混胰岛素产品销售量同比增 长112.38%。较集采前，公司产品销量实现翻倍增长，市场占有率大幅提升。 ➢ 续约加速三代替换二代胰岛素步伐，公司获得采购基础量进一步扩大。本次 分析师 王班 集采首年采购需求量中，三代胰岛素采购需 ...

Investment Rating - The investment rating for the company is "Buy" with a target price of 60.03 CNY, maintaining the previous rating of "Buy" [1][2]. Core Views - The company's core products are experiencing rapid growth, and operational efficiency has significantly improved. The company has won bids for all its centralized procurement products, which are expected to enhance profits. Multiple potential catalysts indicate strong development momentum, justifying the "Buy" rating [1][2]. Summary by Sections Financial Performance - In 2023, the company's revenue reached 2.608 billion CNY, a substantial increase of 52.31% year-on-year. The net profit attributable to shareholders was 297 million CNY, marking a turnaround from losses [1][2]. - For Q1 2024, the company reported revenues of 560 million CNY and a net profit of 96 million CNY, reflecting a year-on-year increase of 95.04% [1][2]. Product Performance - The sales volume of the company's domestic formulation products grew by 66.36% year-on-year in 2023, with long-acting insulin sales increasing by 112.38% [1][2]. - The company has successfully raised prices for its insulin products following centralized procurement, which is expected to significantly boost profits [1][2]. Future Outlook - The company is expected to maintain strong growth due to the price increases of core products and the anticipated launch of new products in developed markets [1][2]. - The forecasted EPS for 2024-2026 is adjusted to 1.19/2.04 CNY (previously 1.05/1.90 CNY) and 2.65 CNY respectively, with a target price maintained at 60.03 CNY, corresponding to a PE of 29X for 2025 [1][2].

根据《上海证券交易所上市公司自律监管指引第 1 号——规范运作》《公司 章程》《审计委员会工作细则》等相关规定，公司第四届董事会审计委员会本着 勤勉尽责的原则，认真履行工作职责，现就 2023 年度工作情况向董事会作如下 报告： 甘李药业股份有限公司 2023 年董事会审计委员会履职情况报告 一、审计委员会基本情况 本公司第四届董事会审计委员会任期自 2022 年 5 月 19 日至 2025 年 5 月 19 日止。截至 2023 年 12 月 31 日，公司第四届董事会审计委员会由独立董事何艳 青女士、郑国钧先生及董事宋维强先生组成，何艳青女士担任主任委员。审计委 员会成员均具有能够胜任审计委员会工作职责的专业知识和工作经验，保证足够 的时间和精力履行委员会的工作职责。2023 年度，审计委员会委员凭借丰富的 行业经验及专业审计、会计知识，在监督及评估外部审计机构的工作、指导公司 内部审计、审阅公司财务报告等方面向董事会提出了专业意见，在公司审计与风 险管理等方面发挥了重要作用。 二、审计委员会 2023 年度会议召开情况 报告期内，本公司董事会审计委员会根据中国证监会《上市公司治理准则》 《公司章程》《 ...

甘李药业股份有限公司董事会审计委员会 对 2023 年度会计师事务所履行监督职责情况报告 根据《国有企业、上市公司选聘会计师事务所管理办法》《上海证券交易所 上市公司自律监管指引第 1 号—规范运作》和甘李药业股份有限公司（以下简称 "公司"）的《公司章程》《董事会审计委员会工作细则》等规定和要求，公司 董事会审计委员会本着勤勉尽责的原则，恪尽职守，认真履职。现将公司董事会 审计委员会对大华会计师事务所（特殊普通合伙）（以下简称"大华会计师事务 所"）2023 年度履行监督职责的情况汇报如下： 一、2023 年度审计会计师事务所基本情况 （一）会计师事务所基本情况 大华会计师事务所成立于 2012 年 2 月 9 日，注册地址为北京市海淀区西四 环中路 16 号院 7 号楼 1101，首席合伙人为梁春。 截至 2023 年末，大华会计师事务所合伙人数量 270 名，注册会计师数量 1,471 名（其中签署过证券服务业务审计报告的注册会计师数量 1,141 名）。 （二）聘任会计师事务所履行的程序 公司第四届董事会第十次会议及 2022 年年度股东大会分别审议通过了《关 于续聘公司 2023 年度会计师事务所及 ...

2022 年限制性股票激励计划 第一个解除限售期解除限售条件成就及回购注销部 分限制性股票的法律意见书 二〇二四年四月 关于甘李药业股份有限公司 北京市中伦律师事务所 北京市中伦律师事务所 北京 • 上海 • 深圳 • 广州 • 武汉 • 成都 • 重庆 • 青岛 • 杭州 • 南京 • 海口 • 东京 • 香港 • 伦敦 • 纽约 • 洛杉矶 • 旧金山 • 阿拉木图 Beijing • Shanghai • Shenzhen • Guangzhou • Wuhan • Chengdu • Chongqing • Qingdao • Hangzhou • Nanjing • Haikou • Tokyo • Hong Kong • London • New York • Los Angeles • San Francisco • Almaty 关于甘李药业股份有限公司 2022 年限制性股票激励计划第一个解除限售期解除限售条件成 就及回购注销部分限制性股票的 法律意见书 致：甘李药业股份有限公司 根据甘李药业股份有限公司（以下简称"甘李药业"、"公司"）与北京市 中伦律师事务所（以下简称"本所"）签订的《法 ...

委托单位：甘李药业股份有限公司 审计单位：大华会计师事务所(特殊普通合伙) 联系电话：86 (10) 5835 0011 关于甘李药业股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 目 录 1、 专项审计报告 2、 附表 二、 甘李药业股份有限公司 2023 年度非经营性资 金占用及其他关联资金往来情况汇总表 1 控股股东及其他关联方资金占用情况的专项说明 （截止 2023 年 12 月 31 日） 甘李药业股份有限公司 目 录 页 次 一、 控股股东及其他关联方资金占用情况的专项说 明 1-2 大华会计师事务所（特殊普通合伙） 北京市海淀区西四环中路 16 号院 7 号楼 12 层 [100039] 电话：86 (10) 5835 0011 传真：86 (10) 5835 0006 www.dahua-cpa.com 控 股 股 东 及 其 他 关 联 方 资 金 占 用 情 况 的 专 项 说 明 大华核字[2024]0011000883 号 甘李药业股份有限公司全体股东： 我们接受委托，依据《中国注册会计师执业准则》审计了甘李药 业股份有限公司（以下简称甘李药业）2023 年 ...

甘李药业股份有限公司 2023 年度独立董事述职报告 作为甘李药业股份有限公司（以下简称"公司"）的独立董事，2023 年本人能 够严格按照《公司法》《证券法》《上市公司治理准则》《上市公司独立董事管理办 法》等法律、法规和《公司章程》的规定，恪尽职守，勤勉尽责，充分发挥独立董事 的独立作用，维护了公司及全体股东的利益。现将 2023 年度本人的工作情况汇报如 下： 一、独立董事基本情况 （一）个人工作履历、专业背景情况 本人，昌增益，公司独立董事，男，1965 年出生，博士，毕业于美国贝勒医学 院。1996 年至 2003 年在清华大学生物系任教；2003 年调北京大学生命科学学院工 作，现任北京大学生命科学学院教授、博士生导师、北京大学跨院系蛋白质科学中 心主任等职务。 作为公司独立董事，任职期间，本人未在公司担任除独立董事以外的其他职务， 与公司、公司的控股股东不存在可能妨碍本人进行独立客观判断的关系，本人也没有 从公司、公司控股股东及其关联方取得额外的、未予披露的其他利益。因此，不存在 影响独立性的情况。 二、2023 年度履职情况 （一）独立董事出席会议情况 1. 出席董事会、股东大会情况 2023 ...

根据中国证监会《上市公司独立董事管理办法》《上海证券交易所上市公司自 律监管指引第 1 号——规范运作》等规定，甘李药业股份有限公司（以下简称"公 司"）董事会，就公司在任独立董事何艳青、郑国钧、昌增益的独立性情况进行评 估并出具如下专项意见： 经核查独立董事何艳青、郑国钧、昌增益的任职经历以及签署的相关自查文件， 上述人员未在公司担任除独立董事以外的任何职务，也未在公司控股股东、实际控 制人的附属企业担任任何职务，与公司以及主要股东、实际控制人之间不存在利害 关系或其他可能妨碍其进行独立客观判断的关系。因此，公司董事会认为，公司独 立董事符合《上市公司独立董事管理办法》《上海证券交易所上市公司自律监管指 引第 1 号——规范运作》等规定中对独立董事独立性的相关要求。 甘李药业股份有限公司 特此报告。 董事会对独立董事独立性自查情况的专项报告 甘李药业股份有限公司 董事会 2024 年 4 月 25 日 ...

Innovation and R&D - The company emphasizes the importance of innovation as the primary driving force for sustainable development, with a commitment to high investment in R&D[2]. - The company is transitioning from imitation to original innovation in the insulin product sector, aiming to develop fourth-generation insulin that offers improved blood sugar control and reduced hypoglycemia risk[2]. - The company has developed new drugs, GZR4 and GZR101 injection solutions, focusing on cutting-edge fields in insulin therapy[2]. - Research and development expenses amounted to 582 million yuan, accounting for 22.30% of total sales revenue[4]. - The company invested 581.57 million yuan in R&D during the reporting period, accounting for 22.30% of total sales revenue, with 501.02 million yuan classified as expensed R&D[36]. - The company is focusing on the research and development of innovative drugs, with a significant increase in R&D investment, accounting for 22.30% of total revenue[104]. - The company has multiple products in the registration phase for the US and EU markets, including insulin analogs, indicating a strong pipeline for future growth[101]. - The company is actively advancing its research pipeline, with projects like GZR18 injection and GZR101 injection currently in clinical trials[68]. - The company has received FDA acceptance for its three biosimilar insulin products, with ongoing preparations for regulatory feedback[68]. - The company aims to enhance R&D capabilities and expand its product pipeline by collaborating with innovative biopharmaceutical companies that have complementary strengths and advanced technologies[119]. Financial Performance - In 2023, the company's operating revenue reached 2.608 billion yuan, representing a year-on-year growth of 52.31%[4]. - The company's net profit attributable to shareholders was 340 million yuan, marking a turnaround from losses in previous years[4]. - The company reported a significant increase in revenue, with a year-over-year growth of 25% in the last fiscal year[15]. - The company achieved a revenue of 2.608 billion yuan, representing a year-on-year growth of 52.31%, and a net profit of 340 million yuan, marking a turnaround from loss to profit[35]. - The company's operating revenue for 2023 was CNY 2.61 billion, an increase of 52.31% compared to CNY 1.71 billion in 2022[25]. - The total net assets attributable to shareholders increased to CNY 10.74 billion, reflecting a growth of 12.07% from CNY 9.59 billion in 2022[25]. - The company reported a significant increase in international sales revenue, which rose by 131.78% year-on-year, contributing CNY 186 million[25]. - The company’s revenue for 2023 reached CNY 2,608.04 million, representing a year-on-year growth of 52.31%[76]. - The net profit attributable to shareholders was CNY 340.07 million, marking a turnaround from loss to profit compared to the same period last year[76]. Market Expansion - The company plans to expand its market presence in Europe and the United States while strengthening its foothold in emerging markets[4]. - The company plans to expand its market presence in Europe and North America, targeting a 15% market share in these regions by 2025[15]. - The company is actively pursuing clinical trials for GZR4 injection in the U.S. market, indicating its commitment to international expansion[37]. - The company is focusing on internationalization, with a strategy to penetrate developed markets like the US and Europe through partnerships and local production[75]. - The company is actively expanding its international customer base and increasing overseas orders, benefiting from stable production capacity and competitive pricing[61]. - The company has successfully registered its insulin products in emerging markets, including a commercial license for glargine insulin injection pen in India as of May 2023, marking a significant milestone in its international expansion efforts[41]. Product Development - The company is currently developing several new products, including GZR101 injection, which is expected to enter clinical trials in Q2 2024[15]. - The company has developed six core insulin products, with three biosimilars receiving formal acceptance from the FDA in the first half of 2023[35]. - GZR4 injection, a fourth-generation insulin analog, aims to reduce injection frequency by over 300 times annually compared to daily formulations, improving patient compliance and quality of life[37]. - The company is the first domestic single-target GLP-1RA to conduct head-to-head efficacy evaluation against semaglutide injection, enhancing its competitive edge in the market[37]. - The company’s oral SGLT-2 inhibitor, Ertugliflozin tablets, is expected to be approved by 2025, expanding the diabetes product line and enhancing market competitiveness[39]. - The company has successfully launched its first oral hypoglycemic drug, DPP-4 inhibitor, in June 2022[60]. - The company is focusing on the development of new drugs, including the GLP-1RA product GZR18, which targets both type 2 diabetes and obesity[60]. Corporate Governance - The company adheres to legal and regulatory requirements to ensure a sound corporate governance structure, with a board of directors consisting of 9 members, including 3 independent directors[121]. - The company maintains independence from its controlling shareholders, ensuring no interference in decision-making and operations, and has established a clear separation of assets and operations[121]. - The company has implemented a robust internal control system that is effectively executed across all levels and processes of its operations[121]. - The company ensures transparent information disclosure, providing equal access to information for all shareholders, particularly minority investors[121]. - The company has established a comprehensive evaluation mechanism to assess and reward directors, supervisors, and senior management based on a multi-dimensional indicator system[132]. Sustainability and Social Responsibility - The company is committed to sustainability, with plans to reduce carbon emissions by 30% over the next five years through innovative manufacturing processes[15]. - The company invested CNY 27,541,800 in environmental protection during the reporting period, reflecting its commitment to sustainable development[156]. - The company reported zero incidents of exceeding emission standards for wastewater and air pollutants during the reporting period[160][159]. - The company has implemented measures for solid waste reduction, resulting in the disposal of 1,599.3045 tons of hazardous waste through qualified vendors[161]. - The company actively participates in charitable activities, including a CNY 10 million donation to support education in Gansu province[176]. - The company has committed to sustainable development by promoting the use of recyclable materials in its employee welfare initiatives[174]. Employee Development - The company has established a digital learning platform to enhance talent development and optimize training systems[144]. - The "Successor Talent Development Program" aims to enhance strategic thinking and global vision among mid-level managers and successors[145]. - The company employs a 70-20-10 learning model, focusing on 70% practical experience, 20% learning from others, and 10% classroom knowledge[145]. - The company collaborates with top universities to cultivate postdoctoral researchers and enhance academic levels in drug research[144]. Risk Management - The company recognizes the risk of a single revenue structure, primarily relying on insulin products, and aims to diversify its product pipeline[118]. - The company faces risks in innovative drug development due to long R&D cycles, high investment, and low success rates, which could adversely affect growth and profitability if new drugs do not meet market demands or face intense competition[119]. - The company will conduct technical assessments and risk management at key stages of R&D projects to reduce risks and track significant milestones during the development process[119].

甘李药业股份有限公司 作为甘李药业股份有限公司（以下简称"公司"）的独立董事，2023 年本人能 够严格按照《公司法》《证券法》《上市公司治理准则》《上市公司独立董事管理办 法》等法律、法规和《公司章程》的规定，恪尽职守，勤勉尽责，充分发挥独立董事 的独立作用，维护了公司及全体股东的利益。现将 2023 年度本人的工作情况汇报如 下： 一、独立董事基本情况 （一）个人工作履历、专业背景情况 本人，何艳青，女，1985 年出生，中国国籍，无永久境外居留权，大学本科， 中国注册会计师，毕业于河北经贸大学。2008 年至 2023 年，任职于北京金华诚信 会计师事务所有限责任公司，担任审计助理、项目经理职务；2024 年至今，担任北 京合方会计师事务所（特殊普通合伙）合伙人；2019 年至今，担任公司独立董事。 （二）是否存在影响独立性的情况说明 2023 年度独立董事述职报告 具体出席情况如下： | 董事姓名 | 本年应参加董 | 亲自出席 | 委托出席 | 缺席次数 | 是否连续两 次未亲自参 | | --- | --- | --- | --- | --- | --- | | | 事会次数 | 次数 | 次数 ...