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博瑞医药:双靶点GLP1/GIP创新药未来可期;首予买入
Zhao Yin Guo Ji· 2024-11-12 05:35
Investment Rating - The report initiates coverage with a "Buy" rating for the company, setting a target price of 44.21 RMB, indicating a potential upside of 47.2% from the current price of 30.03 RMB [3]. Core Insights - The company focuses on a dual strategy of integrating raw materials and formulations, combining generic and innovative drugs, with a strong emphasis on complex formulations and original new drugs. The company has seen rapid revenue growth, achieving 1.18 billion RMB in revenue for 2023, a year-on-year increase of 15.9% [1][12]. - The innovative drug BGM0504, a dual GLP-1/GIP receptor agonist, is positioned as a leading product in the domestic market, with promising clinical data for weight loss and diabetes treatment. The company has initiated Phase III clinical trials for weight loss and is expected to start Phase III trials for diabetes soon [1][26][31]. Company Overview and Development Strategy - The company was founded in 2001 and listed on the STAR Market in November 2019. It operates a business model that balances international and domestic markets, focusing on first-generic, difficult-to-generate, and specialty raw materials, as well as complex formulations and original new drugs [9][10]. - The company has a comprehensive product range covering antiviral, antifungal, immunosuppressive, respiratory, and oncology treatments, with a focus on high-tech and clinically valuable pipelines [10][11]. Financial Performance - In 2023, the company reported a revenue of 1.18 billion RMB, with raw material product revenue of 885 million RMB, and a significant increase in antiviral product revenue due to heightened demand [12][13]. - The company’s net profit for 2023 was 173 million RMB, a decrease of 18.0% from the previous year, primarily due to lower gross margins and increased R&D expenses [16][22]. R&D Investment - The company emphasizes R&D, with R&D expenses reaching 249 million RMB in 2023, accounting for 21.1% of revenue. The focus is on innovative drugs and inhalation formulations, with a significant increase in R&D investment for BGM0504 [22][23]. - BGM0504 has shown promising results in clinical trials, demonstrating significant weight loss and blood sugar control compared to competitors [26][32]. Product Pipeline - The company has multiple products in various stages of clinical trials, including BGM0504 for diabetes and weight loss, and BGC0228 for oncology, indicating a robust pipeline for future growth [24][25][30]. - The company is also advancing its inhalation and iron supplement products, which are expected to contribute to future revenue streams [24][25].
睿智投资|博瑞医药 (688166 CH) - 双靶点GLP1/GIP 创新药未来可期;首予买入
Zhao Yin Guo Ji· 2024-11-07 08:08
Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of 44.21 CNY [4] Core Insights - The company has experienced stable growth in its raw materials and formulations business, achieving a revenue of 1.18 billion CNY in 2023, a year-on-year increase of 15.9% [1] - The company is focusing on complex formulations and innovative drugs, with R&D expenses reaching 249 million CNY in 2023, a 20.1% increase, accounting for 21.1% of revenue [2] - The innovative drug BGM0504 has shown promising results in clinical trials, with a significant weight loss of 18.5% in the 15mg dosage group during the second phase of clinical trials [3] Summary by Sections Revenue Growth - The company reported a revenue of 1.18 billion CNY in 2023, with a 15.9% year-on-year growth, and a revenue of 977 million CNY in the first three quarters of 2024, reflecting a 6.8% increase [1] - The revenue from formulation products reached 110 million CNY in the first half of 2024, marking a 30.4% increase, with formulation products accounting for 17.9% of total sales [1] R&D Focus - The company is prioritizing R&D in inhalation agents and GLP-1 class drugs, with 53.0% of R&D expenses directed towards innovative drugs and inhalation formulations in the first half of 2024, a 105.3% increase year-on-year [2] Clinical Development - BGM0504, a dual agonist for GLP-1/GIP, is in the first tier of domestic formulations, with a 2.76% reduction in HbA1c levels observed in diabetes patients during the second phase of clinical trials [3] - The company has initiated the third phase of clinical trials for BGM0504 for weight loss, with IND approval obtained in the U.S. [3] Financial Projections - Revenue is projected to grow steadily, with expected increases of 9.6%, 11.5%, and 14.5% from 2024 to 2026, reaching 1.29 billion CNY, 1.44 billion CNY, and 1.65 billion CNY respectively [4] - Net profit is forecasted to be 200 million CNY, 230 million CNY, and 290 million CNY for the same period, with growth rates of 13.7%, 16.3%, and 27.9% respectively [4]
博瑞医药:关于召开2024年第三季度业绩说明会的公告
2024-11-05 08:36
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示: 会议召开时间:2024 年 11 月 14 日(星期四)下午 13:00-14:00 会议召开地点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : https://roadshow.sseinfo.com/) 证券代码:688166 证券简称:博瑞医药 公告编号:2024-083 博瑞生物医药(苏州)股份有限公司 关于召开 2024 年第三季度业绩说明会的公告 本次投资者说明会以网络互动形式召开,公司将针对 2024 年第三季度的经 营成果及财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许的 范围内就投资者普遍关注的问题进行回答。 二、 说明会召开的时间、地点 (一)会议召开时间:2024 年 11 月 14 日下午 13:00-14:00 (二)会议召开地点: 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : https://roadshow.sseinfo.com/) (三)会议召开方式:上证路演中心网络互 ...
博瑞医药:临床数据表现优异,海外全面布局
GOLDEN SUN SECURITIES· 2024-11-04 11:12
Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Views - The company has shown excellent clinical data performance, with significant weight loss results from the BGM0504 injection in phase II clinical trials for obesity and type 2 diabetes [1][2]. - The company is actively expanding its international presence, with approvals for BGM0504 injection in the US and IND applications submitted in Indonesia [2]. - The financial outlook is positive, with projected revenue growth from 1.34 billion in 2024 to 1.91 billion in 2026, representing a CAGR of 14.0% to 23.8% [2][3]. Financial Summary - Q3 2024 revenue was 319 million, a decrease of 2.52% year-on-year, while net profit attributable to the parent company was 68.39 million, down 17.34% [1]. - For the first three quarters of 2024, revenue reached 977 million, an increase of 6.77% year-on-year, with a net profit of 174 million, down 7.50% [1]. - The company’s revenue is expected to grow to 1.34 billion in 2024, 1.55 billion in 2025, and 1.91 billion in 2026, with net profits projected at 210 million, 231 million, and 296 million respectively [2][3]. Clinical and R&D Progress - The company has made significant investments in R&D, with Q3 2024 R&D expenses amounting to 69.62 million, an increase of 15.21% year-on-year [1]. - The BGM0504 injection has shown promising results in clinical trials, with weight loss percentages of 8.4%, 12.0%, and 13.8% across different dosage groups [1]. Market Position and Strategy - The company is focusing on both innovative drugs and raw materials, with multiple approvals and submissions for its products in various international markets [2]. - The total market capitalization of the company is approximately 12.16 billion [4].
博瑞医药:公司信息更新报告:BGM0504临床进展较快,吸入制剂进展顺利
KAIYUAN SECURITIES· 2024-11-02 13:12
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has shown steady revenue growth in the first three quarters of 2024, with revenue reaching 977 million yuan, a year-on-year increase of 6.77%. However, the net profit attributable to shareholders decreased by 7.5% to 177 million yuan [4] - The clinical progress of BGM0504 is rapid, with significant advancements in inhalation formulations. The company is optimistic about its long-term development and maintains its profit forecast for the years 2024-2026 [4][6] - The company’s R&D investment has increased by 35.3% year-on-year, accounting for 22.69% of its operating revenue, indicating a strong commitment to innovation [6] Financial Performance Summary - In Q3 2024, the company achieved revenue of 319 million yuan, a decrease of 2.52% year-on-year, while the net profit attributable to shareholders was 71 million yuan, down 13.73% year-on-year. Excluding the impact of R&D expenses, the net profit grew by 16.11% [4] - The gross margin for Q3 2024 was 63.58%, an increase of 0.42 percentage points year-on-year, while the net margin was 20.22%, a decrease of 3.71 percentage points [4] - The company’s projected net profit for 2024-2026 is estimated at 217 million yuan, 227 million yuan, and 250 million yuan respectively, with corresponding P/E ratios of 56.1, 53.6, and 48.6 [4][7] R&D and Product Development - BGM0504 has received ethical approval for its Phase III clinical trial for weight loss indications, with the first subject already enrolled. The diabetes indication has also received communication approval from CDE to proceed with Phase III clinical trials [6] - The company has made significant progress in its inhalation formulations, with several products either approved or in various stages of clinical trials [6] Expense Ratios - The company’s R&D expense ratio has increased to 21.74% in the first three quarters of 2024, reflecting a focus on innovation and product development [5]
博瑞医药:2024年三季报点评:0504降糖减重数据优秀,原料药制剂业务稳健
Minsheng Securities· 2024-10-30 22:31
Investment Rating - The report maintains a "Recommended" rating for the company [2][4]. Core Insights - The company achieved a revenue of 977 million yuan in the first three quarters of 2024, representing a year-on-year growth of 6.77%. However, the net profit attributable to shareholders decreased by 7.50% to 177 million yuan [2]. - The BGM0504 clinical trial data showed promising results, with significant weight loss and improved glycemic control in participants. The drug is progressing to Phase III clinical trials [2]. - The company is expanding its raw material and formulation production capacity to meet the demand for innovative drugs and difficult-to-generate formulations [2]. Financial Forecasts - The projected revenues for 2024, 2025, and 2026 are 1.339 billion yuan, 1.529 billion yuan, and 1.762 billion yuan, respectively, with growth rates of 13.6%, 14.2%, and 15.2% [3][5]. - The net profit attributable to shareholders is expected to be 211 million yuan in 2024, 237 million yuan in 2025, and 268 million yuan in 2026, with growth rates of 4.0%, 12.4%, and 13.0% [3][5]. - The company’s PE ratios are projected to be 61, 54, and 48 for the years 2024, 2025, and 2026, respectively [3][5]. Clinical Development - The BGM0504 injection for weight loss and type 2 diabetes treatment has met its expected goals in Phase II clinical trials, with significant reductions in body weight and waist circumference observed [2]. - The company has received ethical approval for the Phase III clinical trial for the weight loss indication, and the first participant has been enrolled [2]. Production Capacity Expansion - The company is expanding its production facilities, including the completion of various construction phases for raw material and formulation production bases [2].
博瑞医药:2024年三季报点评:业绩符合预期,创新管线稳步推进,研发费用影响当期利润
Soochow Securities· 2024-10-30 03:30
Investment Rating - The investment rating for the company is "Accumulate" (maintained) [1] Core Views - The company's Q3 2024 performance met expectations, with revenue of 977 million yuan (+6.77% year-on-year) and a net profit attributable to shareholders of 177 million yuan (-7.5% year-on-year) [2] - R&D expenses significantly impacted profits, with a Q3 R&D investment of 79 million yuan (+30.53% year-on-year), leading to a 16.11% year-on-year increase in net profit when excluding R&D costs [3] - The innovation pipeline is progressing smoothly, with promising clinical data for BGM0504 in diabetes and weight loss indications [4] Summary by Sections Financial Performance - Q3 2024 revenue was 319 million yuan (-2.52% year-on-year), with a net profit of 71 million yuan (-13.73% year-on-year) [2][3] - The gross margin for Q3 was 63.58% (+0.42 percentage points), while the net margin was 20.22% (-3.71 percentage points) [3] R&D and Innovation - The company is focusing on high-difficulty generics and has made significant progress in its innovation pipeline, including the completion of Phase II clinical trials for BGM0504 [4] - The clinical data for weight loss showed significant average weight reduction percentages of 10.8%, 16.2%, and 18.5% for different dosage groups [4] Earnings Forecast and Valuation - The forecast for net profit attributable to shareholders for 2024-2026 has been adjusted to 2.08 billion yuan, 2.58 billion yuan, and 2.95 billion yuan respectively, with corresponding P/E ratios of 61, 50, and 43 [5] - The company maintains a positive outlook based on the continuous improvement of its product matrix and the successful advancement of its innovation pipeline [5]
博瑞医药(688166) - 2024 Q3 - 季度财报
2024-10-29 09:01
Financial Performance - The company's operating revenue for Q3 2024 was ¥319,137,248.68, a decrease of 2.52% compared to the same period last year[2]. - The net profit attributable to shareholders for Q3 2024 was ¥71,044,018.70, down 13.73% year-on-year[2]. - The basic earnings per share for Q3 2024 was ¥0.17, a decrease of 10.53% compared to the same period last year[2]. - Total operating revenue for the first three quarters of 2024 reached RMB 976,825,695.67, an increase of 6.8% compared to RMB 914,877,843.44 in the same period of 2023[22]. - Net profit for the first three quarters of 2024 was RMB 146,757,526.84, down 17.0% from RMB 176,740,694.87 in the same period of 2023[23]. - The total profit for the first three quarters of 2024 was RMB 168,076,343.14, a decrease from RMB 197,688,288.52 in the previous year[23]. - Earnings per share for the first three quarters of 2024 were RMB 0.42, compared to RMB 0.45 in the same period of 2023[23]. Research and Development - R&D investment totaled ¥78,874,621.38 in Q3 2024, an increase of 30.53% compared to the same period last year, representing 24.71% of operating revenue[2][7]. - The company reported a net profit growth of 16.11% when excluding the impact of R&D expenses for innovative drugs[4]. - The company has maintained a "R&D-driven" strategy, increasing investment in products like BGM0504 injection[4]. - The company achieved significant progress in the clinical trials for its innovative drug BGM0504, with the weight loss indication entering Phase III trials in China and receiving ethical approval for the first subject enrollment[13]. - The company has submitted 10 new domestic patent applications and received 9 new domestic patent authorizations in Q3 2024, bringing the total patent applications to 490, including 434 invention patents[15]. - The company has completed the Phase I clinical trial for the injectable BGC0228[13]. - The company has received IND approval for BGM0504 in the United States for weight loss indication, with the first subject already enrolled[15]. - The company has received clinical trial approval for the inhalation powder of Salmeterol and Fluticasone, with the first subject already enrolled[14]. Assets and Liabilities - Total assets at the end of Q3 2024 were ¥4,878,532,811.80, a decrease of 3.05% from the end of the previous year[3]. - Total equity attributable to shareholders at the end of Q3 2024 was ¥2,352,381,122.67, a decrease of 0.69% from the previous year[3]. - Current assets decreased from CNY 1,839,738,327.73 to CNY 1,382,517,329.28, representing a decrease of about 24.87%[19]. - Cash and cash equivalents dropped significantly from CNY 998,045,685.92 to CNY 505,357,865.57, a reduction of approximately 49.3%[19]. - Accounts receivable increased from CNY 282,978,228.31 to CNY 369,536,455.40, reflecting an increase of about 30.54%[19]. - Total liabilities decreased from CNY 2,614,247,828.99 to CNY 2,536,193,149.01, a decrease of approximately 2.93%[20]. - Long-term borrowings decreased from CNY 1,184,658,415.12 to CNY 1,104,249,061.43, a decline of about 6.77%[20]. - Total equity decreased from CNY 2,417,583,546.93 to CNY 2,342,339,662.79, a decrease of approximately 3.11%[20]. - The company reported a significant reduction in short-term borrowings from CNY 156,873,727.68 to CNY 122,138,205.34, a decrease of about 22.2%[20]. - The company’s inventory slightly decreased from CNY 344,627,860.71 to CNY 339,742,470.71, a reduction of approximately 1.14%[19]. - The company’s long-term equity investments decreased from CNY 43,490,102.12 to CNY 39,325,778.89, a decline of about 9.93%[19]. Cash Flow and Investments - The net cash flow from operating activities for the year-to-date period was ¥119,589,702.03, an increase of 21.01% year-on-year[2]. - Cash outflow from investment activities totaled $523.15 million, an increase from $419.79 million in the previous period, resulting in a net cash flow from investment activities of -$424.87 million, compared to -$367.59 million previously[25]. - Cash inflow from financing activities was $595.96 million, slightly down from $619.28 million in the previous period, with net cash flow from financing activities at -$173.77 million, a decrease from $66.68 million[25]. - The net increase in cash and cash equivalents was -$477.72 million, compared to -$205.88 million in the previous period, leading to an ending cash balance of $493.32 million[25]. - The company reported a significant increase in cash paid for fixed assets, intangible assets, and other long-term assets, totaling $251.05 million, compared to $300.32 million previously[25]. - Cash paid for investments rose to $272.10 million from $115.60 million, indicating a strategic focus on expanding investment activities[25]. - Cash paid for debt repayment increased to $627.88 million from $447.12 million, reflecting a higher commitment to managing debt obligations[25]. - Cash dividends and interest payments totaled $118.86 million, up from $100.51 million, indicating a stable return to shareholders[25]. - The impact of exchange rate changes on cash and cash equivalents was positive at $1.33 million, contrasting with a negative impact of -$3.81 million in the previous period[25]. - The company did not receive any cash from minority shareholders' investments during the current period, compared to $60 million previously[25]. Accounting and Reporting - The company has adopted new accounting standards starting in 2024, which may affect future financial reporting[26].
博瑞医药:自愿披露关于BGM0504注射液减重适应症获得Ⅲ期临床试验伦理批件的公告
2024-10-21 09:48
证券代码:688166 证券简称:博瑞医药 公告编号:2024-081 博瑞生物医药(苏州)股份有限公司 自愿披露关于 BGM0504 注射液减重适应症 获得Ⅲ期临床试验伦理批件的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 近日,博瑞生物医药(苏州)股份有限公司(以下简称"公司")全资子公司 博瑞新创生物医药科技(无锡)有限公司(以下简称"博瑞新创")自主研发的 BGM0504 注射液减重适应症的Ⅲ期临床研究方案通过了牵头医院北京大学人民 医院伦理审查委员会的审批,获得了《北京大学人民医院伦理审查委员会伦理审 查批件》。现将相关情况公告如下: 一、药品基本情况 BGM0504 注射液是公司自主研发的 GLP-1(胰高血糖素样肽 1)和 GIP(葡 萄糖依赖性促胰岛素多肽)受体双重激动剂,属于境内外均未上市化学药品 1 类 创新药。BGM0504 注射液可激动 GIP 和 GLP-1 下游通路,产生控制血糖、减重 和治疗非酒精性脂肪性肝炎(NASH)等生物学效应,展现多种代谢疾病治疗潜 力。 三、风险提示 1、公司 ...
博瑞医药(688166) - 2024年10月14日投资者调研报告
2024-10-15 10:24
编号:2024-010 证券代码:688166 证券简称:博瑞医药 博瑞生物医药(苏州)股份有限公司 投资者关系活动记录表 | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------|-----------------------------------------------------|---------------------------------|-----------------------------------------------|----------------------------------------------------|------------------------------------|------------|--------------| | 投资者关系活 \n动类别 | □特定对象调研 \n□媒体采访 \n□新闻发布会 \n□现场参观 | \n \n \n | □分析师会议 \n□业绩说明会 \n□路演活动 \n■其他 | 电话会议 | | | | | | 宏利基金 | 玖 ...