证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 李强 S1350524040001 Liqiang01@huayuanstock.com 市场表现： -17.00% 3.00% 23.00% 信立泰 沪深300 相关研究 首次覆盖报告 2024 年 09 月 13 日 信立泰 (002294.SZ ) 买入（首次覆盖） ——创新药商业化渐入佳境，在研管线持续丰富 投资要点： ➢ 公司事件：公司发布 2024 年半年报，2024 上半年实现营业收入 20.4 亿元，同比增长 21.3%，实现归母 净利润 3.4 亿元（同比增长 1.9%）；24Q2，实现营业收入 9.5 亿元，同比增长 19.4%，实现归母净利润 1.4 亿元（同比增长 13.5%），符合市场预期。 ➢ 创新药商业化推广加大，销售费用率有所增长。毛利率方面，24H1 公司整体毛利率为 71.1%，23 年同 期为 68.9%，预计主要系高毛利率创新药占比提升所致；费用率方面，2024 上半年，公司销售、管理和 研发费用率分别为 36.3%、6.6%和 9.9%，23 ...

Investment Rating - The investment rating for the company is "Buy," indicating an expected return exceeding 10% relative to the CSI 300 index over the next six months [5]. Core Views - The company has achieved comprehensive growth in its main business segments, with a reported revenue of 2.043 billion yuan for the first half of 2024, representing a year-on-year increase of 21.28%. The net profit attributable to shareholders reached 344 million yuan, up 1.92% year-on-year [2][3]. - The company is advancing its innovation pipeline, with multiple projects currently in Phase III clinical trials. The R&D investment for the first half of 2024 was 460 million yuan, accounting for 22.51% of revenue [2][3]. - The gross margin has improved, reaching 71.13%, an increase of 2.20 percentage points compared to the previous year. The company has sufficient cash reserves of 938 million yuan, which supports ongoing R&D efforts [2][3]. Summary by Sections Financial Performance - For the first half of 2024, the company's revenue from raw materials was 234 million yuan (up 15.73%), from formulations was 1.631 billion yuan (up 19.54%), and from medical devices was 137 million yuan (up 49.62%). Other revenues amounted to 40 million yuan (up 55.31%) [2]. - The basic earnings per share for the first half of 2024 was 0.31 yuan, reflecting a year-on-year increase of 3.33% [2]. R&D and Innovation - The company has two products approved for market launch and four products under application for approval. The R&D pipeline is progressing well, with ongoing patient recruitment for clinical trials [2][3]. Market Position and Outlook - The company is expected to see continued revenue growth, with projected diluted EPS of 0.56 yuan, 0.64 yuan, and 0.75 yuan for 2024-2026, corresponding to dynamic P/E ratios of 49.51, 43.77, and 37.27, respectively [3].

Investment Rating - The report maintains a "Buy" rating for the company [3] Core Views - The company's performance in H1 2024 met expectations, with a revenue of 2.043 billion yuan, a year-on-year increase of 21.28%, and a net profit of 344 million yuan, up 1.92% year-on-year. The second quarter saw a revenue of 952 million yuan, growing 19.44% year-on-year, and a net profit of 144 million yuan, increasing 13.54% year-on-year [1] - The report highlights the gradual formation of a commercialization ladder for chronic disease products, with significant growth in both innovative and generic drug segments [1] Financial Performance - In H1 2024, R&D investment reached 460 million yuan, accounting for 22.51% of revenue, while sales expenses increased by 44.24% year-on-year to 741 million yuan, representing a sales expense ratio of 36.27% [1] - The company reported a net cash flow from operating activities of 533 million yuan, a year-on-year increase of 50.81% [1] Segment Analysis 1. **Innovative Drugs**: The market share of the innovative drug "Xinlitai" increased by over 20% year-on-year. New approvals include a compound formulation for hypertension and a DPP-4 inhibitor for type 2 diabetes [1] 2. **Generic Drugs**: The impact of the "Taijia" renewal gradually diminished, with a quarter-on-quarter sales increase in H1 2024. The penetration rate of Cefuroxime Sodium improved post-collection, and revenue from Teriparatide exceeded a 50% year-on-year growth [1] 3. **Other Businesses**: Revenue from APIs grew over 15%, and medical device income increased by 49.62% year-on-year, beginning to turn profitable [1] R&D Progress - The company has submitted applications for several new drugs, including S086 for hypertension and various treatments for chronic kidney disease. The overseas pipeline is progressing well, with ongoing clinical trials for multiple candidates [1] Profit Forecast and Valuation - The profit forecast for 2024-2026 has been raised, with expected net profits of 631 million yuan, 734 million yuan, and 907 million yuan, representing year-on-year growth rates of 8.8%, 16.2%, and 23.6% respectively. The corresponding P/E ratios are projected to be 54x, 47x, and 38x [1]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company is positioned as a leader in the cardiovascular chronic disease sector, with a promising pipeline of innovative products expected to contribute to revenue growth [6] - The company reported a revenue of 2.04 billion yuan for H1 2024, representing a year-on-year increase of 21.3%, and a net profit of 330 million yuan, up 8.5% [6] - The impact of price declines on existing products is gradually being released, stabilizing revenue, while new products are expected to drive future income growth [6] Summary by Sections Financial Performance - For H1 2024, the company achieved a revenue of 2.04 billion yuan, with Q2 revenue at 950 million yuan, reflecting a growth of 19.4% [6] - The net profit for H1 2024 was 330 million yuan, with Q2 net profit at 130 million yuan, showing an increase of 17.7% [6] - The company forecasts net profits of 616 million yuan, 691 million yuan, and 811 million yuan for 2024, 2025, and 2026 respectively, with corresponding PE ratios of 54.6, 48.6, and 41.4 [6][8] Product Pipeline and Innovation - The company has a rich pipeline of innovative drugs, with several products expected to be approved and launched in the near future, including SAL0107 and benzoic acid for treating hypertension and heart failure [6] - The new product, Ennadustat, was launched in June 2023 and is expected to significantly contribute to revenue after being included in the national medical insurance catalog [6] Market Position and Growth Potential - The company is experiencing a gradual decrease in the impact of price reductions from existing generic drugs, while the proportion of innovative drugs is continuously increasing [6] - The company is well-positioned for future growth with a strong focus on innovative drug development and a strategic approach to market entry [6]

证券代码：002294 证券简称：信立泰 编号：2024-043 深圳信立泰药业股份有限公司 关于"质量回报双提升"行动方案的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 深圳信立泰药业股份有限公司（下称"公司"或"信立泰"）为贯彻落实"活 跃资本市场、提振投资者信心"及"要大力提升上市公司质量和投资价值，要采 取更加有力有效措施，着力稳市场、稳信心"的指导思想，坚持把高质量发展作 为首要任务，因地制宜发展新质生产力，增强投资者信心，维护全体股东利益， 结合自身发展战略、经营情况及财务状况，公司制定"质量回报双提升"行动方 案。具体举措如下： 一、聚焦慢病领域，创新引领发展 信立泰始终把创新的意识、创新的精神、创新的技术融入企业发展命脉，致 力于发展成为推动国内医药工业创新、打造产业新质生产力的"领航者"。作为 创新型医药企业，公司始终致力于为慢性疾病患者提供高质量的药品和服务，凭 借持续的创新研发和精准的市场布局，加速向"中国最具影响力的创新国际化医 药企业"的目标迈进。 公司以医药制造业为主体，进行多层次产业链布局，在海外自建创新药研发 平台，在国 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has shown a significant recovery in revenue, exceeding expectations, with innovative products gaining traction [1] - The company is actively expanding its product offerings in the cardiovascular field and is making progress in international markets [2] - The financial forecasts for 2024-2026 indicate a steady growth trajectory in both revenue and net profit, driven by new product launches and a recovery in existing product sales [2] Financial Performance Summary - For the first half of 2024, the company reported revenue of 2.043 billion yuan, a year-on-year increase of 21.28%, and a net profit attributable to shareholders of 344 million yuan, up 1.92% year-on-year [1] - The gross profit margin for the reporting period was 71.13%, an increase of 2.19 percentage points year-on-year, while the operating cash flow net amount was 533 million yuan, reflecting a year-on-year increase of 50.81% [1] - The company expects revenues of 4.04 billion yuan in 2024, 4.73 billion yuan in 2025, and 5.40 billion yuan in 2026, with respective year-on-year growth rates of 19.9%, 17.1%, and 14.3% [2] Product Development and Pipeline - The company has multiple products progressing to the registration stage, including innovative drugs for hypertension and chronic heart failure, which are expected to drive future growth [1] - The company is also advancing its international clinical trials for innovative biological drugs, indicating a strategic focus on global market expansion [1][2] Financial Projections - The projected net profit for 2024 is 670 million yuan, with expected growth rates of 15.7%, 18.0%, and 12.7% for the years 2024, 2025, and 2026 respectively [2] - The company's P/E ratios are projected to be 46X in 2024, 39X in 2025, and 35X in 2026, reflecting a positive outlook on valuation [2]

信立泰(002294) / 化学制药 / 公司点评 / 2024.08.26 信立坦渠道拓展顺利，研发管线丰富 投资评级:增持(维持) 核心观点 | --- | --- | |----------------|------------| | 基本数据 | 2024-08-26 | | 收盘价(元) | 27.82 | | 流通股本(亿股) | 11.15 | | 每股净资产(元) | 7.03 | | 总股本(亿股) | 11.15 | 最近 12 月市场表现 -15% -7% 1% 9% 17% 25% 信立泰 沪深300 分析师 张文录 SAC 证书编号：S0160517100001 zhangwenlu@ctsec.com 分析师 赵则芬 SAC 证书编号：S0160524040003 zhaozf@ctsec.com 相关报告 1. 《高血压产品布局完善，仿制药负面 影响削弱》 2024-03-27 2. 《泰嘉中标单价略有下行，研发进展 顺利》 2023-08-25 3. 《信立坦加速渠道下沉，新产品蓄势 待发》 2023-03-29 证券研究报告 事件：2024 年上半年，信立泰实现营收 20.4 ...

华英证券有限责任公司 关于深圳信立泰药业股份有限公司 调整部分募投项目内部投资结构并延期 的核查意见 华英证券有限责任公司（以下简称"华英证券"、"保荐机构"）作为深圳信 立泰药业股份有限公司（以下简称"信立泰"或者"公司"）2020 年非公开发行 A 股股票的保荐机构，根据《上市公司监管指引第 2 号——上市公司募集资金管 理和使用的监管要求》《深圳证券交易所股票上市规则》及《深圳证券交易所上 市公司自律监管指引第 1 号——主板上市公司规范运作》等相关规定，对信立泰 调整部分募投项目内部投资结构并延期的事项进行了审慎核查。核查的具体情况 及核查意见如下： 一、募集资金的基本情况 单位：万元 根据临床研究实际进展情况，公司结合自身业务发展需要，在"心脑血管及 相关领域创新药研发项目——SAL0951 恩那司他中国 I/III 期临床研究及上市注 册项目"（下称"SAL0951 项目"）实施主体、募集资金投资用途及投资总额不 发生变化的前提下，拟对该项目的内部投资结构进行调整，增加新的适应证临床 研究。具体调整情况如下： 1 | | | | | 截至期末投入 | 项目达到 | | --- | --- | -- ...

证券代码：002294 证券简称：信立泰 编号：2024-043 深圳信立泰药业股份有限公司 关于调整部分募投项目内部投资结构并延期的公告 现就具体情况公告如下： 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 深圳信立泰药业股份有限公司（以下简称"公司"）于 2024 年 8 月 23 日召 开第六届董事会第四次会议、第六届监事会第四次会议，审议通过了《关于调整 部分募投项目内部投资结构并延期的议案》，同意公司调整 2020 年非公开发行 募集资金投资项目"心脑血管及相关领域创新药研发项目——SAL0951 恩那司 他中国 I/III 期临床研究及上市注册项目"的内部投资结构并延期。 该事项未改变募集资金投入金额，未改变募投项目实施主体，亦不存在募集 资金用途变更的其他情形。本事项尚需提交公司股东大会审议。 一、 募集资金的基本情况 （一） 实际募集资金金额、资金到位时间 经中国证券监督管理委员会证监许可[2021]663 号文核准《关于核准深圳信 立泰药业股份有限公司非公开发行股票的批复》，公司向特定投资者发行人民币 普通股 68,800,535 股，每股 ...

证券代码：002294 证券简称：信立泰 编号：2024-038 深圳信立泰药业股份有限公司 第六届董事会第四次会议决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 深圳信立泰药业股份有限公司（下称"公司"）第六届董事会第四次会议于 2024 年 8 月 23 日 14 时，在公司会议室以现场、通讯及书面方式召开，会议通 知于 2024 年 8 月 12 日以电子邮件方式送达。应参加董事 9 人，实际参加董事 9 人，其中，董事叶澄海、董事沈清、独立董事王学恭以通讯方式出席会议，独立 董事刘来平以书面方式出席会议，出席董事符合法定人数。全体监事、部分高级 管理人员列席会议，其中监事会主席李爱珍、监事李扬兵以通讯方式列席会议。 会议由公司董事长叶宇翔先生主持，本次会议召开符合法律法规和《公司章程》 等有关规定。 与会董事审议并形成如下决议： 一、会议以 9 人同意，0 人反对，0 人弃权，审议通过了《深圳信立泰药业 股份有限公司 2024 年半年度报告》及报告摘要。 该报告已经董事会审计委员会审议通过，董事会审议通过了上述报告。 （《深圳信立泰药业股份有 ...