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健友股份:健友股份关于达肝素钠注射液通过仿制药质量和疗效一致性评价的公告
2024-11-04 09:42
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-079 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 关于达肝素钠注射液通过仿制药 质量和疗效一致性评价的公告 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、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")于近 日收到国家药品监督管理局(以下简称"NMPA")签发的达肝素钠注射液 0.3ml: 7500AⅩaIU 规格的药品补充申请批准证书(药品批准文号为国药准字 H20201000,通知书编号为 2024B05042),批准本品通过仿制药质量和疗效一致 性评价。现将相关情况公告如下: 一、药品的基本情况 (一)药品名称:达肝素钠注射液 (二)适 应 症:治疗急性深静脉血栓。预防急性肾功能衰竭或慢性肾功能 不全者进行血液透析和血液过滤期间体外循环系统中的凝血。治疗不稳定型冠状 动脉疾病,如:不稳定型心绞痛和非 Q 波型心肌梗死。预防与手术有关的 ...
健友股份2024年三季报点评:盈利能力环比改善,加码生物药转型
Investment Rating - The report maintains a "Cautious Accumulate" rating for the company [2][3]. Core Views - The company's profitability has improved on a quarter-on-quarter basis, with a focus on high-end formulations and a transition to biopharmaceuticals, indicating a positive long-term growth outlook [2]. - For the first three quarters of 2024, the company reported revenue of 3.088 billion yuan, a year-on-year decrease of 1.72%, and a net profit attributable to shareholders of 6.06 million yuan, down 27.82% year-on-year. The third quarter alone saw revenue of 945 million yuan, a year-on-year increase of 12.79%, with a net profit of 201 million yuan, down 6.54% year-on-year [2]. - The report adjusts the EPS forecast for 2024-2026 to 0.52, 0.69, and 0.92 yuan respectively, down from previous estimates of 0.56, 0.74, and 0.96 yuan, and sets a target price of 16.56 yuan for 2025, up from 13.44 yuan [2]. Financial Summary - The gross profit margin for the first three quarters of 2024 was 41.41%, a decrease of 7.99 percentage points year-on-year, primarily due to high base prices of heparin raw materials in the same period last year. The gross profit margin for Q3 was 44.07%, down 0.32 percentage points year-on-year but up 2.30 percentage points quarter-on-quarter [2]. - The selling expense ratio decreased to 6.27%, down 3.56 percentage points year-on-year, mainly due to reduced promotional expenses for formulations. The management expense ratio increased to 3.93%, up 0.58 percentage points year-on-year, while the R&D expense ratio rose to 7.00%, up 0.23 percentage points [2]. - The net profit margin attributable to shareholders for the first three quarters of 2024 was 19.62%, down 7.09 percentage points year-on-year, with Q3 showing a net profit margin of 21.24%, an increase of 1.23 percentage points quarter-on-quarter [2]. Strategic Initiatives - The company is intensifying its strategic transition towards biopharmaceuticals and high-end formulations, having obtained multiple drug registration approvals in the first half of 2024. As of 2023, it holds 97 overseas drug registration approvals and 28 domestic approvals, leading the industry in the number of ANDA approvals [2]. - The company is advancing its capabilities in peptide and complex formulation technologies, with ongoing development of four biosimilar projects in 2023. Collaborations with other firms are also underway to enhance its product offerings in the high-end market [2].
健友股份:肝素原料药价格压力趋缓,关注生物药出海节奏
Ping An Securities· 2024-10-31 09:32
Investment Rating - The report maintains a "Recommendation" rating for the company [2][7]. Core Views - The company has faced pressure on revenue and profit due to high base prices of heparin raw materials, with a reported revenue of 3,088 million yuan for the first three quarters of 2024, reflecting a decrease of 1.72% year-on-year, and a net profit of 606 million yuan, down 27.82% year-on-year [5][6]. - The report anticipates a new price recovery cycle for heparin by the end of 2024, as the pressure from raw material prices is expected to ease [5][6]. - The company is positioned as a high-quality overseas injectable drug commercialization platform, with a significant number of ANDA approvals and FDA-approved production lines, indicating strong potential for profitability in overseas markets [6][7]. Financial Summary - Revenue projections for 2024-2026 are set at 43.44 billion yuan, 53.22 billion yuan, and 66.24 billion yuan respectively, with net profit expectations of 8.67 billion yuan, 11.53 billion yuan, and 15.07 billion yuan [7]. - The company’s gross margin is expected to improve from 44.07% in Q3 2024, indicating a recovery in profitability [5]. - The report highlights a significant increase in the company's earnings per share (EPS), projected to rise from -0.12 yuan in 2023 to 0.54 yuan in 2024, and further to 0.93 yuan by 2026 [10][11].
健友股份:健友股份关于召开2024年第三季度业绩说明会的公告
2024-10-30 08:39
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-077 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 会议召开方式:上证路演中心网络互动 投资者可于 2024 年 11 月 05 日(星期二) 至 11 月 11 日(星期一)16:00 前 登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 nkf-pharma@nkf-pharma.com.cn 进行提问。公司将在说明会上对投资者普遍关 注的问题进行回答。 南京健友生化制药股份有限公司(以下简称"公司")已于 2024 年 10 月 31 日发布公司 2024 年三季度报告,为便于广大投资者更全面深入地了解公司 2024 年三季度经营成果、财务状况,公司计划于 2024 年 11 月 12 日 上午 09:00-10:00 举行 2024 年第三季度业绩说明会,就投资者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2024 年三季度的经营 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 ...
健友股份:健友股份第五届董事会第十一次会议决议公告
2024-10-30 08:39
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-076 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 具体内容详见公司于上交所官网(www.sse.com.cn)披露的《健友股份 2024 年三季度报告》。 表决结果:同意 6 票赞成,0 票反对,0 票弃权。 公司召开了第五届董事会审计委员会 2024 年第三次会议,发表意见如下: 全体委员同意公司 2024 年第三季度报告的财务信息,并同意提交董事会审议。 第五届董事会第十一次会议决议公告 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、准确性和完整性承担个别及连带责任。 一、董事会会议召开情况 南京健友生化制药股份有限公司(以下简称"公司")第五届董事会第十一 次会议的通知已于 2024 年 10 月 22 日以电话及电子邮件的方式向各位董事发出, 会议于 2024 年 10 月 30 日上午 9 点整在公司会议室召开。本次会议通过现场方 式召开,应到董事 6 人,实到董事 6 人,其中 ...
健友股份(603707) - 2024 Q3 - 季度财报
2024-10-30 08:39
Financial Performance - The company's operating revenue for Q3 2024 was ¥945,350,270.02, representing a year-over-year increase of 12.79%[2] - The net profit attributable to shareholders for the same period was ¥200,766,736.72, showing a decrease of 6.54% compared to the previous year[2] - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥179,553,333.37, down 15.29% year-over-year[2] - The basic earnings per share for Q3 2024 was ¥0.12, a decrease of 7.69% compared to the same period last year[2] - Total operating revenue for the first three quarters of 2024 was CNY 3,088,009,007.42, a decrease of 1.7% compared to CNY 3,141,918,005.97 in the same period of 2023[15] - Net profit for the first three quarters of 2024 was CNY 605,775,481.17, down 28% from CNY 839,329,356.88 in the previous year[16] - Earnings per share (EPS) for the first three quarters of 2024 was CNY 0.37, compared to CNY 0.52 in the same period of 2023[17] Assets and Liabilities - The total assets at the end of the reporting period were ¥9,426,678,825.90, reflecting a decrease of 1.02% from the end of the previous year[3] - As of September 30, 2024, the company's total assets amounted to approximately RMB 9.43 billion, a slight decrease from RMB 9.52 billion at the end of 2023[12] - The total liabilities decreased to CNY 3,159,751,028.40 from CNY 3,725,766,674.92 year-over-year[16] - The total equity attributable to shareholders of the parent company increased to CNY 6,270,407,620.76 from CNY 5,801,966,942.85[16] Cash Flow - The net cash flow from operating activities for the year-to-date was ¥1,055,077,327.83, down 9.91% year-over-year[2] - In the first three quarters of 2024, the cash inflow from operating activities was CNY 3,291,019,552.74, a decrease of 8.2% compared to CNY 3,584,028,187.68 in the same period of 2023[18] - The net cash flow from operating activities for the first three quarters of 2024 was CNY 1,055,077,327.83, down from CNY 1,171,194,935.25 in 2023, reflecting a decline of 9.9%[18] - Cash inflow from investment activities totaled CNY 2,067,000,653.47, significantly higher than CNY 1,487,036,287.24 in the previous year, marking an increase of 39%[19] - The net cash flow from investment activities was negative at CNY -1,970,502,625.53, compared to CNY -202,849,848.73 in the same period last year, indicating a substantial increase in cash outflow[19] - Cash inflow from financing activities was CNY 3,382,028,500.99, up from CNY 2,178,132,810.93 in 2023, representing a growth of 55.1%[19] - The net cash flow from financing activities improved to CNY 646,617,220.72, compared to a negative CNY -666,207,700.54 in the previous year[19] - The total cash and cash equivalents at the end of the period stood at CNY 626,536,891.47, an increase from CNY 544,894,730.63 at the end of the previous year[19] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 16,997, indicating a stable shareholder base[6] - The company has a strong shareholder base, with Jiangsu Coastal Development Group holding approximately 21.30% of shares as of September 30, 2024[10] - The company has no significant changes in the participation of major shareholders in securities lending and borrowing activities[10] Expenses and Costs - Total operating costs increased to CNY 2,430,007,182.20, up 11.3% from CNY 2,184,444,946.57 year-over-year[16] - The company reported a decrease in net profit due to increased expenses and lower product prices, leading to a year-to-date decline of 33.41% in net profit attributable to shareholders after deducting non-recurring gains and losses[6] - The cash paid to employees increased to CNY 317,655,358.91, up from CNY 284,072,242.08, reflecting an increase of 11.8%[18] - The cash paid for taxes rose to CNY 300,230,962.48, compared to CNY 272,257,424.61 in the previous year, indicating an increase of 10.3%[18] Research and Development - The company has been focusing on research and development, with development expenditures increasing to approximately RMB 452.69 million from RMB 293.05 million, a growth of about 54.6%[13] - Research and development expenses for the first three quarters of 2024 were CNY 216,228,047.16, slightly up from CNY 212,803,589.87 in the previous year[16] Other Financial Metrics - The return on equity (ROE) for the reporting period was 3.17%, an increase of 0.07 percentage points compared to the previous year[3] - Non-recurring gains and losses for the current period totaled ¥21,213,403.35, with significant contributions from government subsidies and investment income[5] - Other comprehensive income after tax for the first three quarters of 2024 was CNY 7,305,302.77, compared to CNY 4,661,522.58 in the previous year[17] - The company's cash and cash equivalents decreased to approximately RMB 902.47 million from RMB 1.21 billion at the end of 2023, representing a decline of about 25.4%[12] - Accounts receivable increased to approximately RMB 952.94 million, up from RMB 751.30 million, reflecting a growth of about 26.8%[12] - Inventory decreased to approximately RMB 3.60 billion from RMB 4.16 billion, indicating a reduction of about 13.4%[12] - The company's total current liabilities decreased to approximately RMB 2.22 billion from RMB 3.09 billion, a decline of about 28.1%[13] - The company reported a significant increase in trading financial assets, rising to approximately RMB 1.05 billion from RMB 681.99 million, an increase of about 54.3%[12] - The company's long-term equity investments remained stable, with no significant changes reported[13] - The company reported a financial expense of CNY 72,868,430.33, compared to a financial income of CNY 65,049,275.88 in the same period last year[16]
健友股份:健友股份关于不向下修正健友转债转股价格的公告
2024-10-29 09:49
南京健友生化制药股份有限公司 关于不向下修正"健友转债"转股价格的公告 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、准确性和完整性承担个别及连带责任。 重要内容提示: | 股票代码:603707 | 股票简称:健友股份 | 公告编号:2024-073 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 4、公司于2021年7月15日起因实施2020年年度利润分配方案,"健友转债"的 转股价格由42.01元/股调整为32.20元/股。具体内容详见公司2021年7月9日披露的 《南京健友生化制药股份有限公司关于"健友转债"转股价格调整公告》(公告编 号:2021-060)。 5、公司于2022年6月10日起因公司实施2021年限制性股票激励计划预留授予, "健友转债"的转股价格由32.20元/股调整为32.19元/股。具体内容详见公司2022年 6月9日披露的《南京健友生化制药股份有限公司关于"健友转债"转股价格调整公 告》(公告编号:2022-043) 经上海证券交易所自律监管决定书[2020]134号 ...
健友股份:健友股份关于子公司产品注射用盐酸多西环素获得美国FDA批准的公告
2024-10-29 09:49
一、药品的基本情况 | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-074 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 关于子公司产品注射用盐酸多西环素 获得美国 FDA 批准的公告 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、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")子公司健 进制药有限公司(以下简称"健进制药")于近日收到美国食品药品监督管理局 (以下简称"美国 FDA")签发的注射用盐酸多西环素,100 mg/瓶的 ANDA 批准 通知(ANDA 号:218053)。现将相关情况公告如下: 公司高度重视药品研发,严格控制药品研发、生产、销售环节的质量和安全。 但产品的生产和销售容易受国家政策、市场环境等不确定因素的影响,有可能存 在销售不达预期等情况。敬请广大投资者谨慎决策,注意防范投资风险。 二、药品其他相关情况 公司于 2024 年 10 月 29 日收到美国 FDA 的 ...
健友股份:健友股份关于“健友转债”预计满足转股价格修正条款的提示性公告
2024-10-22 08:43
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-072 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 关于"健友转债"预计满足 转股价格修正条款的提示性公告 上述方案须经参加表决的全体股东所持表决权的三分之二以上通过方可实 施。股东进行表决时,持有本次可转债的股东应当回避。修正后的转股价格应不 低于前项规定的股东大会召开日前二十个交易日公司股票交易均价和前一交易 日公司股票交易均价。 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个别及连带责任。 一、可转债的发行上市概况 经中国证券监督管理委员会《关于核准南京健友生化制药股份有限公司公开 发行可转换公司债券的批复》(证监许可[2020]603 号)核准,南京健友生化制 药股份有限公司(以下简称"公司")公开发行了 5,031,900 张可转换公司债券 (以下简称"可转债"或"健友转债"),每张面值人民币 100 元,发行总额人 民币 5.0319 亿元,本次可转债存续期限 ...
健友股份:健友股份关于获得国家药品监督管理局注射用泮托拉唑钠药品注册批件的公告
2024-10-14 09:14
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2024-071 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 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个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")于近 日收到国家药品监督管理局(以下简称"NMPA")签发的注射用泮托拉唑钠 40mg (按 C₁₆H₁₅F₂N₃O₄S 计)规格的药品注册证书(药品批准文号为国药准字 H20249036),现将相关情况公告如下: 一、药品的基本情况 (一)药品名称:注射用泮托拉唑钠 (二)适 应 症:十二指肠溃疡;胃溃疡;中、重度反流性食管炎;十二指 肠溃疡、胃溃疡、急性胃黏膜病变、复合性胃溃疡等引起的急性上消化道出血。 (三)剂 型:注射剂 (四)规 格:40mg(按 C₁₆H₁₅F₂N₃O₄S 计) (五)药品批准文号:国药准字 H20249036 (六)申 请 人:南京健友生化制药股份有限公司 关于获得国家 ...