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博瑞医药:临床数据表现优异,海外全面布局
国盛证券· 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
开源证券· 2024-11-02 13:12
f憶证券 医药生物/化学制药 公 司 研 究 BGM0504 临床进展较快,吸入制剂进展顺利 博瑞医药(688166.SH) 2024 年 11 月 02 日 投资评级:买入(维持) | --- | --- | |-------------------------|-------------| | 日期 | 2024/11/1 | | 当前股价 ( 元 ) | 28.79 | | 一年最高最低 ( 元 ) | 41.39/19.63 | | 总市值 ( 亿元 ) | 121.63 | | 流通市值 ( 亿元 ) | 121.63 | | 总股本 ( 亿股 ) | 4.22 | | 流通股本 ( 亿股 ) | 4.22 | | 近 3 个月换手率 (%) | 161.34 | 股价走势图 -60% -40% -20% 0% 20% 40% 2023-11 2024-03 2024-07 博瑞医药 沪深300 数据来源:聚源 相关研究报告 《2024 年上半年业绩稳健增长, BGM0504 及吸入制剂进展顺利—公 司信息更新报告》-2024.8.25 《减重降糖产品进展顺利,吸入制剂 新赛道曙光初现—公司首次覆盖 ...
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
民生证券· 2024-10-30 22:31
博瑞医药(688166.SH)2024 年三季报点评 [盈利预测与财务指标 Table_Forcast] 0504 降糖减重数据优秀,原料药制剂业务稳健 2024 年 10 月 31 日 ➢ 事件:2024 年 10 月 30 日,博瑞医药发布 2024 年三季报业绩。公司前三 季度实现收入 9.77 亿元,同比增长 6.77%,归母净利润 1.77 亿元,同比减少 7.50%,扣非净利润 1.74 亿元,同比下降 7.50%。单季度看,Q3 实现收入 3.19 亿元,同比减少 2.52%,归母净利润 0.71 亿元,同比减少 13.73%,扣非净利润 0.68 亿元,同比减少 17.34%。 ➢ BGM0504 二期临床数据优异,后续临床正常推进中。BGM0504 注射液减 重和 2 型糖尿病治疗两项适应症在国内的 II 期临床试验达成预期目标,减重适应 症中第 24 周时 5mg 组、10mg 组和 15mg 组体重较基线平均降幅百分比(扣 除安慰剂)分别为 10.8%、16.2%和 18.5%,腰围较基线平均降幅(扣除安慰剂) 分别为 6.4cm、8.8cm 和 10.2cm,次要指标提升显著降低多项心 ...
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
东吴证券· 2024-10-30 03:30
证券研究报告·公司点评报告·化学制药 博瑞医药(688166) 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 2024 年 10 月 29 日 增持(维持) | --- | --- | --- | --- | --- | --- | |------------------------------|--------|---------|--------|--------|--------| | 盈利预测与估值 [Table_EPS] | 2022A | 2023A | 2024E | 2025E | 2026E | | 营业总收入(百万元) | 1017 | 1180 | 1310 | 1515 | 1749 | | 同比( % ) | (3.33) | 15.94 | 11.02 | 15.72 | 15.41 | | 归母净利润(百万元) | 239.62 | 202.47 | 208.11 | 257.62 | 294.91 | | 同比( % ) | (1.77) | (15.51) | 2.79 | 23.79 | 14.48 | | EPS- 最新摊薄(元 / 股) ...
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 ...
博瑞医药:0504核心减重指标完美达成,具备BIC和大单品潜力
民生证券· 2024-10-15 06:03
博瑞医药(688166.SH)事件点评 0504 核心减重指标完美达成,具备 BIC 和大单品潜力 2024 年 10 月 15 日 [盈利预测与财务指标 Table_Forcast] ➢ 事件:10 月 13 日,博瑞医药发布 BGM0504 注射液减重适应症 II 期临床 试验数据,给药 26-30 周整体耐受性、安全性良好,各剂量组受试者在体重、腰 围等核心减重指标方面均明显优于安慰剂组;在次要疗评指标方面如心血管代谢 风险指标、增加胰岛素敏感性的相关指标、患者结局报告指标等较基线均有改善, 且优于安慰剂组。 ➢ BGM0504 减重 II 期临床试验达到主要终点和关键次要终点,展现出良好 的综合代谢获益。1)核心减重指标:目标剂量给药第 4 周,5mg 组、10mg 组、 15mg 组体重较基线平均降幅百分比(扣除安慰剂)分别为 5.2%、7.0%和 9.5%; 第 24 周分别为 10.8%、16.2%和 18.5%,腰围较基线平均降幅(扣除安慰剂) 分别为 7.9cm、11.7cm 和 13.4cm。2)心血管代谢风险指标:目标剂量给药第 24 周,5mg 组、10mg 组和 15mg 组收缩压较 ...
博瑞医药:事件点评:0504核心减重指标完美达成,具备BIC和大单品潜力
民生证券· 2024-10-15 06:00
博瑞医药(688166.SH)事件点评 0504 核心减重指标完美达成,具备 BIC 和大单品潜力 2024 年 10 月 15 日 [盈利预测与财务指标 Table_Forcast] ➢ 事件:10 月 13 日,博瑞医药发布 BGM0504 注射液减重适应症 II 期临床 试验数据,给药 26-30 周整体耐受性、安全性良好,各剂量组受试者在体重、腰 围等核心减重指标方面均明显优于安慰剂组;在次要疗评指标方面如心血管代谢 风险指标、增加胰岛素敏感性的相关指标、患者结局报告指标等较基线均有改善, 且优于安慰剂组。 ➢ BGM0504 减重 II 期临床试验达到主要终点和关键次要终点,展现出良好 的综合代谢获益。1)核心减重指标:目标剂量给药第 4 周,5mg 组、10mg 组、 15mg 组体重较基线平均降幅百分比(扣除安慰剂)分别为 5.2%、7.0%和 9.5%; 第 24 周分别为 10.8%、16.2%和 18.5%,腰围较基线平均降幅(扣除安慰剂) 分别为 7.9cm、11.7cm 和 13.4cm。2)心血管代谢风险指标:目标剂量给药第 24 周,5mg 组、10mg 组和 15mg 组收缩压较 ...
博瑞医药:自愿披露关于BGM0504注射液减重适应症Ⅱ期临床试验数据的公告
2024-10-13 07:34
证券代码:688166 证券简称:博瑞医药 公告编号:2024-080 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 Ⅱ期临床试验数据的公告 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 注射液治疗非糖尿病的超重或肥胖的Ⅱ期临床试验达成预期目标。现将 相关情况公告如下: 一、BGM0504 注射液Ⅱ期临床试验情况 (一)Ⅱ期临床方案 BGM0504 注射液已完成的 II 期临床试验(CTR20233198)是一项在非糖尿 病的超重或肥胖受试者中多次给药的安全性、耐受性、PK/PD 特征和有效性的随 机、双盲、安慰剂平行对照的临床研究。本项研究共纳入了 120 例中国非糖尿病 的超重或肥胖受试者,各组在体重、腰围、BMI 等方面的基线特征基本均衡。 (二)II 期试验初步结果 BGM0504 注射液治疗超重或肥胖的 II 期临床试验 ...