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荣昌生物(09995) - 2024 - 年度业绩
2025-03-27 12:16
Financial Performance - For the fiscal year ending December 31, 2024, the company's product sales revenue was approximately RMB 1,699.1 million, representing a 61.9% increase from RMB 1,049.2 million in the same period last year[4]. - The total revenue for the fiscal year was RMB 1,710.2 million, with a gross profit of RMB 1,367.4 million[9]. - Revenue increased from RMB 1,076.1 million in 2023 to RMB 1,710.2 million in 2024, driven by strong sales of the autoimmune product TaiTasi and the oncology product VidiSita[38]. - For the year ended December 31, 2024, the company's revenue increased to RMB 1,710,152 thousand, up from RMB 1,076,130 thousand in 2023, representing a growth of approximately 58.8%[63]. - The company reported a net loss of RMB 1,468,362,000 for the year ended December 31, 2024, compared to a net loss of RMB 1,511,229,000 in 2023, indicating a reduction in losses of approximately 2.8%[64]. - Total comprehensive loss for the year was RMB 1,499,240,000, down from RMB 1,570,147,000 in the previous year, reflecting a decrease of about 4.5%[64]. - The net loss for the year decreased to RMB 1,468.36 million in 2024 from RMB 1,511.23 million in 2023, showing a slight improvement in financial performance[48]. Research and Development - Research and development expenses increased by RMB 233.5 million or 17.9% to RMB 1,539.8 million for the fiscal year[9]. - The company has a comprehensive pipeline with over ten candidate drugs, seven of which are in clinical development targeting more than twenty indications[10]. - The company is actively exploring Taisai for other autoimmune diseases, including plans for a Phase III clinical study for membranous nephropathy[20]. - The company is conducting a Phase II clinical trial for RC148 in advanced lung cancer, progressing smoothly as of December 31, 2024[34]. - The company is focused on drug development and has received approval for the comprehensive marketing application of its drug, TaiTasiPu, in November 2023[69]. - The company is committed to adhering to corporate governance codes as outlined in the listing rules[106]. Clinical Trials and Approvals - The company received FDA Fast Track Designation for its product RC18 (Taitai) for the treatment of primary Sjögren's syndrome in March 2024[5]. - RC48 (Widi) showed positive results in a Phase III clinical trial for HER2-positive metastatic breast cancer, achieving the primary endpoint[6]. - Taisai (RC18) received full NMPA approval in China in November 2023 and was successfully included in the national medical insurance drug catalog by the end of 2023[14]. - The company initiated a Phase III clinical trial for Taisai in China for the treatment of IgA nephropathy in the first half of 2023, with patient recruitment completed by May 2024[16]. - The company submitted a Biologics License Application (BLA) for Taisai for rheumatoid arthritis in August 2023, with approval from NMPA expected in July 2024[15]. - The company has completed a Phase II clinical trial for Vidisicimab in HER2-overexpressing urinary tract cancer patients, leading to a multi-center Phase II registration trial[21]. - A Phase III clinical trial comparing Vidisicimab combined with chemotherapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) is ongoing in China, with patient enrollment completed in August 2024[23]. Financial Position and Liabilities - The company's total liabilities to assets ratio increased to 63.9% as of December 31, 2024, compared to 37.8% in 2023, indicating a higher leverage position[51]. - The company's total liabilities increased significantly to RMB 3,512,318,000 in 2024 from RMB 2,091,074,000 in 2023, marking an increase of approximately 68%[66]. - The net asset value decreased to RMB 1,986,201,000 in 2024 from RMB 3,437,269,000 in 2023, a decline of about 42.3%[66]. - The company has cumulative losses of RMB 4,321,871,000 as of December 31, 2024, indicating ongoing financial challenges[69]. - The company maintains that its available funds and unused bank credit are sufficient to support its normal operations, research, and production activities for at least the next 12 months[69]. Market and Strategic Focus - The company aims to become a leading player in the global biopharmaceutical industry, focusing on unmet medical needs in autoimmune, oncology, and ophthalmology diseases[10]. - The company is one of the few Chinese biotech firms that have commercialized two products, RC18 and RC48[10]. - The company is actively pursuing new drug applications and clinical trials to expand its product pipeline[108]. - The core products include RC18 (brand name: 泰愛®), RC48 (brand name: 愛地希®), and RC28-E[107]. - The company is focused on developing antibody-drug conjugates (ADCs) for targeted cancer therapies[106]. Governance and Compliance - The company is subject to regulatory oversight by the National Medical Products Administration (NMPA) in China[108]. - The board of directors includes both executive and non-executive members, ensuring a diverse governance structure[109]. - The group has adopted revised international financial reporting standards, including IFRS 16 and IAS 1, with no impact on its financial position or performance[73]. - The company emphasizes the uncertainty in successfully developing and selling its core products, advising shareholders to act cautiously[105].
荣昌生物(688331) - 华泰联合证券有限责任公司关于荣昌生物制药(烟台)股份有限公司2024年度募集资金存放和使用情况专项核查报告
2025-03-27 12:01
募集资金年度存放和使用情况专项核查报告 华泰联合证券有限责任公司 关于荣昌生物制药(烟台)股份有限公司 2024 年度募集资 金存放和使用情况专项核查报告 华泰联合证券有限责任公司(以下简称"华泰联合证券"或"保荐机构") 作为荣昌生物制药(烟台)股份有限公司(以下简称"荣昌生物"、"公司"或 "发行人")首次公开发行股票并在科创板上市的保荐机构,根据《证券发行上 市保荐业务管理办法》《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(2022 年修订)》《上海证券交易所科创板股票上市规则》《上 海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》等法律法规的 规定,对荣昌生物在 2024 年度募集资金存放与使用情况进行了核查,核查情况 如下: 一、募集资金的基本情况 (一)实际募集资金金额及资金到账情况 经中国证券监督管理委员会《关于同意荣昌生物制药(烟台)股份有限公司 首次公开发行股票注册的批复》(证监许可[2022]62 号)核准,公司于 2022 年 3 月 31 日首次公开发行普通股(A 股)5,442.6301 万股,每股面值 1 元,每股发 行价格人民币 48.00 ...
荣昌生物(688331) - 2024 Q4 - 年度财报
2025-03-27 12:00
Financial Performance - RemeGen reported a significant increase in revenue, reaching approximately $150 million, representing a year-over-year growth of 25%[14]. - The company’s operating revenue for 2024 reached ¥1,716,861,688.03, a year-on-year increase of 58.54% compared to ¥1,082,953,432.23 in 2023[21]. - The net profit attributable to shareholders of the listed company for 2024 was -¥1,468,360,802.55, showing a reduction in losses compared to -¥1,511,229,176.70 in 2023[21]. - The company reported a net profit margin of 20%, reflecting strong operational efficiency and cost management strategies[14]. - The company achieved a revenue of 1.717 billion RMB in 2024, a 58.54% increase from 1.083 billion RMB in the same period last year, driven by strong sales of core products Tai'ai® and Aidiqi®[32]. - The company reported a quarterly operating revenue of ¥507,987,407.80 in Q4 2024, with a net profit attributable to shareholders of -¥396,934,163.65[25]. - The company reported a significant increase in long-term borrowings by 42.27% to RMB 1,195,878,046.86, reflecting a strategy to leverage financing for growth[149]. - The company reported a gross margin of 60%, up from 55% in the previous quarter[198]. Research and Development - The company is committed to maintaining a significant scale of R&D investment for ongoing clinical research and global clinical trials[3]. - RemeGen's total R&D investment for the year reached ¥1,539,777,961.92, an increase of 17.87% compared to ¥1,306,306,793.92 in the previous year[105]. - Research and development expenses accounted for 89.69% of operating revenue in 2024, a decrease of 30.93 percentage points from 120.62% in 2023[22]. - The company has a pipeline of products covering multiple disease treatment areas under development[3]. - The company is actively developing new products, with three new drug candidates expected to enter clinical trials by the end of the year[14]. - The company has established three R&D centers in Yantai, Shanghai, and California, focusing on preclinical development and clinical trials of innovative biopharmaceutical products[74]. - The company has a comprehensive, end-to-end R&D and industrialization system for innovative biopharmaceuticals, covering all key stages from drug discovery to large-scale production[115]. - The company has implemented a comprehensive procurement management system to ensure the quality of materials and services required for R&D and production[77]. Market Expansion and Strategy - The company is focusing on expanding its market presence in Europe and North America, targeting a 15% market share in these regions within the next three years[14]. - RemeGen anticipates continued growth, projecting revenue to exceed $200 million in the next fiscal year, indicating a growth rate of 33%[14]. - The company is actively pursuing international clinical trials for its products, including Tai'asi'pu for SLE, indicating a strategy for global market expansion[47]. - The company aims to become a leading biopharmaceutical company in China and a world-class player by focusing on the discovery, development, and commercialization of innovative biopharmaceuticals for major diseases[178]. - The company plans to commercialize and clinically develop its product RC18 (Taitasip) for various indications, having completed a Phase III trial for systemic lupus erythematosus in 2022[180]. - The company is advancing the clinical development of RC28, a dual-target candidate drug for various eye diseases, which is the first of its kind to enter clinical trials globally[181]. - The company is actively promoting global multi-center clinical trials for its core products, aiming for early market approval and international expansion[182]. Corporate Governance and Compliance - The company received a standard unqualified audit report from Ernst & Young Hua Ming[4]. - The company has no violations of decision-making procedures for external guarantees[7]. - The company has established an international clinical and registration system to ensure global registration and commercialization of products[183]. - The board of directors consists of 9 members, including 3 independent directors, ensuring effective governance and decision-making[189]. - The company adheres to strict information disclosure management, ensuring timely and accurate communication with investors[190]. Risks and Challenges - The company faces potential short-term losses due to high expenses related to new drug applications and market promotion[3]. - The company emphasizes the risks associated with forward-looking statements regarding future plans and strategies[6]. - The company faces risks related to regulatory approvals and market competition, which could impact future revenue and profitability[123]. Human Resources and Management - The management team consists of experts with over 20 years of experience in the pharmaceutical industry, focusing on innovative drug development and commercialization strategies[119]. - The company has a total of 926 R&D personnel, accounting for 30.88% of the total workforce, down from 36.18% in the previous period[112]. - The average salary of R&D personnel is ¥48.52 thousand, an increase from ¥34.91 thousand in the previous period[112]. - The total pre-tax compensation for directors, supervisors, and senior management during the reporting period amounted to CNY 2,693.88 million[196].
荣昌生物:2024年报净利润-14.68亿 同比增长2.85%
Tong Hua Shun Cai Bao· 2025-03-27 11:47
Financial Performance - The company reported a basic earnings per share of -2.73 yuan for 2024, an improvement of 2.5% compared to -2.80 yuan in 2023 [1] - The net profit for 2024 was -1.468 billion yuan, showing a slight improvement of 2.85% from -1.511 billion yuan in 2023 [1] - The operating revenue increased significantly by 58.54% to 1.717 billion yuan in 2024, compared to 1.083 billion yuan in 2023 [1] - The return on equity was -54.07% in 2024, worsening from -35.52% in 2023 [1] - The net asset per share decreased by 42.25% to 3.65 yuan in 2024 from 6.32 yuan in 2023 [1] Shareholder Structure - The top ten unrestricted shareholders collectively hold 24.03406 million shares, accounting for 68.36% of the circulating shares, with a change of 914,400 shares from the previous period [2] - HKSCC NOMINEES LIMITED remains the largest shareholder with 18.95667 million shares, representing 53.93% of the total share capital [3] - New entrants to the top ten shareholders include China Minsheng Bank's fund and a new investment fund from China Bank, while E Fund's healthcare fund and Shanghai Liyi Investment Management have exited the top ten [3] Dividend Distribution - The company has announced no dividend distribution or capital increase for the current period [4]
荣昌生物(688331)3月24日主力资金净流入1386.20万元
Sou Hu Cai Jing· 2025-03-24 08:15
荣昌生物(688331)3月24日主力资金净流入 1386.20万元 金融界消息 截至2025年3月24日收盘,荣昌生物(688331)报收于36.66元,上涨4.59%,换手率3.6%, 成交量5.82万手,成交金额2.11亿元。 资金流向方面,今日主力资金净流入1386.20万元,占比成交额6.57%。其中,超大单净流入390.13万 元、占成交额1.85%,大单净流入996.07万元、占成交额4.72%,中单净流出流入747.09万元、占成交额 3.54%,小单净流出2133.28万元、占成交额10.11%。 荣昌生物最新一期业绩显示,截至2024三季报,公司营业总收入12.09亿元、同比增长57.10%,归属净 利润107142.66万元,同比减少3.96%,扣非净利润109739.38万元,同比减少3.45%,流动比率1.356、速 动比率0.956、资产负债率58.54%。 天眼查商业履历信息显示,荣昌生物制药(烟台)股份有限公司,成立于2008年,位于烟台市,是一家以 从事医药制造业为主的企业。企业注册资本54433.2083万人民币,实缴资本40181.9202万人民币。公司 法定代表人为王威 ...
本周医药板块下跌2.72%,礼来加强IBD赛道布局
Great Wall Securities· 2025-03-04 07:20
证券研究报告 | 行业周报 2025 年 03 月 02 日 医药 本周医药板块下跌 2.72%,礼来加强 IBD 赛道布局 | 股票 | 股票 | 投资 | EPS (元) | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2024E | 2025E | 2024E | 2025E | | 002755.SZ | 奥赛康 | 买入 | 0.13 | 0.2 | 110.38 | 71.75 | | 01952.HK | 云顶新耀-B | 买入 | -2.93 | -0.12 | - | - | | 02105.HK | 来凯医药-B | 买入 | -0.9 | -1 | - | - | | 600079.SH | 人福医药 | 增持 | 1.33 | 1.59 | 14.95 | 12.51 | | 688192.SH | 迪哲医药 | 增持 | -2.01 | -1.33 | -23.91 | -36.13 | | 688315.SH | 诺禾致源 | 买入 | 0.47 | 0.53 | 36.68 | 32. ...
荣昌生物(688331) - 2024 Q4 - 年度业绩
2025-02-27 08:35
Financial Performance - The company achieved total operating revenue of 171,540.42 million yuan, a year-on-year increase of 58.40%[3] - The net profit attributable to the parent company was -146,786.25 million yuan, with a decrease in net profit excluding non-recurring gains and losses of -150,039.33 million yuan[5] - The basic earnings per share were -2.73 yuan, showing a slight improvement from -2.80 yuan in the previous year[3] - The weighted average return on net assets decreased to -54.06%, compared to -35.52% in the previous year[3] - The company expects a net loss for 2024, but with a trend towards reduced losses compared to the previous year[5] Assets and Equity - Total assets at the end of the reporting period were 549,914.78 million yuan, a decrease of 0.53% from the beginning of the period[4] - The equity attributable to the parent company decreased by 42.21% to 198,638.60 million yuan[4] Sales and Revenue Growth - The company reported a significant increase in sales revenue from innovative drugs, particularly from Tai Tasi Pi and Vidi Xi Tuo Monoclonal Antibody[7] - The gross profit margin of products continued to grow, while the sales expense ratio significantly decreased[5] Research and Development - The company is in the process of advancing multiple innovative drug candidates in critical trial phases, leading to increased R&D investment[5]
荣昌生物:收入将快速增加,股东净亏损将逐年缩小
中泰国际证券· 2025-01-22 14:23
Investment Rating - The report maintains a "Buy" rating for Rongchang Biologics with a target price adjusted to HKD 19.00 from HKD 21.80 [4][5][14]. Core Insights - The company is expected to see a significant increase in revenue, with a forecasted sales revenue of approximately RMB 1.715 billion for 2024, representing a year-on-year growth of nearly 60% [1]. - Shareholder net losses are projected to decrease by about RMB 410 million to approximately RMB 1.47 billion compared to the previous year [1]. - The main product, Taitasip, is anticipated to drive high revenue growth in 2024, particularly in indications such as lupus [1][2]. Revenue and Loss Forecast - Revenue forecasts for 2024-2026 have been raised by 6.1%, 2.6%, and 1.1% respectively, reflecting the company's strong sales performance [3]. - Despite an increase in sales expense forecasts, shareholder net losses are still expected to narrow year-on-year [3]. Product Development and Approvals - The company is making progress in the approval and development of new indications for its main products, Taitasip and Vidisizumab, with potential approvals expected in 2025 for several new indications [2]. - New product applications are anticipated to be submitted within the year, aligning with the company's development timeline [2]. Financial Data Summary - The financial data indicates a significant recovery trajectory, with total revenue expected to grow from RMB 768 million in 2022 to RMB 3.084 billion by 2026 [12]. - Shareholder net losses are projected to decrease from RMB 999 million in 2022 to RMB 438 million by 2026, indicating a substantial improvement in financial health [12].
荣昌生物(688331) - 2024 Q4 - 年度业绩预告
2025-01-16 07:46
Revenue Projections - The company expects a revenue of approximately CNY 1,715 million for 2024, an increase of about CNY 632 million or 58% compared to the previous year[3]. - In 2023, the company reported a revenue of CNY 1,083 million and a total loss of CNY 1,511 million[6]. Net Loss Forecast - The projected net loss attributable to the parent company for 2024 is approximately CNY 1,470 million, a decrease of about CNY 41 million or 3% compared to the previous year[3]. - The expected net loss attributable to the parent company, excluding non-recurring gains and losses, is approximately CNY 1,498 million, a decrease of about CNY 45 million or 3% compared to the previous year[3]. Research and Development - The company is advancing its new drug research pipeline, with multiple innovative drugs in critical trial stages, leading to increased R&D investment[8]. Sales Performance - Sales revenue from Taitasip and Vidisitamab is growing rapidly, contributing to an increase in product gross margin[8]. - The sales expense ratio has significantly decreased, indicating improved operational efficiency[8]. Financial Reporting and Uncertainties - The total amount of non-recurring gains and losses for the year has not changed significantly[9]. - As of the announcement date, the company has not identified any major uncertainties affecting the accuracy of the performance forecast[10]. - The forecast data is preliminary and subject to change pending the audited financial report for 2024[11].
荣昌生物:监事会关于公司2022年A股限制性股票激励计划之A类权益及B类权益对应归属期归属名单的核查意见
2024-12-30 11:41
荣昌生物制药(烟台)股份有限公司监事会 2024 年 12 月 30 日 1 权益及 B 类权益对应归属期归属名单的核查意见 荣昌生物制药(烟台)股份有限公司(以下简称"公司")监事会根据《中 华人民共和国公司法》(以下简称"《公司法》")、《中华人民共和国证券法》(以 下简称"《证券法》")、《上市公司股权激励管理办法》(以下简称"《管理办法》")、 《上海证券交易所科创板股票上市规则》(以下简称"《上市规则》")等相关法律、 法规及规范性文件和《荣昌生物制药(烟台)股份有限公司章程》(以下简称"《公 司章程》")的有关规定,对公司 2022 年 A 股限制性股票激励计划(以下简称"本 激励计划")之 A 类权益第二个归属期及 B 类权益首次授予第一个归属期符合归 属条件的激励对象名单进行审核,发表核查意见如下: 本次拟归属的激励对象符合《公司法》《证券法》等法律、法规和规范性文 件以及《公司章程》规定的任职资格,符合《管理办法》《上市规则》等法律、 法规和规范性文件规定的激励对象条件,符合本激励计划规定的激励对象范围, 其作为公司本激励计划激励对象的主体资格合法、有效,激励对象获授限制性股 票的归属条件已 ...