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微芯生物:厚积薄发,收入增长在前方
财通证券· 2024-11-19 12:23
Investment Rating - The investment rating for the company is "Buy" (首次) [2] Core Views - The company is positioned in a large market with few competitors for its pipeline indications, including the development of drugs for MSS/pMMR colorectal cancer, small cell lung cancer, and pancreatic cancer [4][5] - The breakthrough clinical results of the combination therapy of Sidabone for MSS/pMMR colorectal cancer have been recognized in the 2024 CSCO guidelines, indicating significant potential for market entry [63] - The company has achieved substantial revenue growth, with projected revenues of 6.73 billion, 8.76 billion, and 11.93 billion yuan for 2024, 2025, and 2026 respectively, reflecting a strong growth trajectory [6][111] Summary by Sections Company Overview - The company is a pioneer in the field of original innovative drugs in China, having launched multiple first-in-class drugs and established a comprehensive drug discovery platform [21][22] - The company has a clear equity structure and stable management team, which is crucial for its long-term growth [23] Revenue Growth and Financial Performance - The company reported a revenue of 4.81 billion yuan for the first three quarters of 2024, a 38.02% increase year-on-year, primarily driven by sales of Sidabone and Xiglitazar [30] - The company is expected to achieve a net profit of 0.43 billion yuan by 2026, indicating a turnaround from previous losses [111] Product Pipeline and Market Potential - Sidabone has shown significant potential in treating MSS/pMMR colorectal cancer, with clinical trials demonstrating its efficacy in combination with other therapies [5][63] - Xiglitazar has rapidly gained traction in the type 2 diabetes market, with sales expected to grow significantly following its approval for use in combination therapies [64][100] Clinical Development and Innovations - The company is advancing its pipeline with promising candidates like Xioroni, which is expected to enter the market for small cell lung cancer, and has shown better clinical efficacy compared to existing treatments [85][89] - The company is also exploring treatments for MASH, with early clinical data indicating potential benefits [78][83] Financial Projections and Valuation - The company is projected to maintain a strong revenue growth rate, with a price-to-sales ratio (PS) of 13.28, 10.21, and 7.50 for the years 2024, 2025, and 2026 respectively [111][116] - The financial outlook is supported by the successful commercialization of its existing products and the anticipated approval of new therapies [106][111]
微芯生物(688321) - 投资者关系活动记录表2024年11月13日
2024-11-15 07:37
Group 1: Company Performance - In the first three quarters of 2024, the company achieved approximately 481 million CNY in revenue, a year-on-year increase of 38.02% [1] - Sales of Sidabamine increased by 24.01% year-on-year, with revenue growth of 16.73% [1] - Sales of Seglitazone saw a remarkable year-on-year increase of 322.98%, with revenue growth of 414.65% [1] Group 2: Research and Development Progress - The II phase clinical study of Seglitazone for treating MASH (CGZ203 trial) was selected for an oral presentation at the 2024 American Liver Meeting [1] - The clinical trial application for the innovative drug CS231295 for tumor treatment has been accepted by CDE [1] - The company is committed to providing affordable, innovative drugs that meet clinical needs, focusing on patient demands [1] Group 3: Competitive Advantages - Sidabamine's DEB regimen for DLBCL is the first global III phase registered clinical study targeting initial treatment for MYC/BCL-2 positive DLBCL, showing significant clinical benefits [2] - Sidabamine is the preferred option for both transplant-eligible and non-eligible relapsed/refractory PTCL, with a strong recommendation in CSCO guidelines [3] - CS231295 is a multi-target protein kinase inhibitor with significant anti-tumor activity and good blood-brain barrier permeability, offering new treatment options for specific tumors [5] Group 4: Market Strategy and Future Plans - The company is actively preparing for the III phase clinical study of Seglitazone for MASH and is open to overseas collaboration opportunities [4] - The company participated in the national medical insurance negotiations for Seglitazone and Sidabamine, with final pricing subject to negotiation results [6]
微芯生物:核心产品快速增长,西格列他钠MASH数据积极
太平洋· 2024-11-04 02:18
Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [12][13]. Core Insights - The company's core products are experiencing rapid growth, particularly the sales of Westgliptin, which saw a year-on-year sales increase of 322.98% and revenue growth of 414.65% in the first three quarters of 2024 [4]. - The company reported a total revenue of 481 million yuan for the first three quarters of 2024, representing a year-on-year increase of 38.02% [3]. - The company has received positive data from the Phase II study of Westgliptin, which showed significant improvements in liver fat and fibrosis indicators [5]. Financial Performance - In Q3 2024, the company achieved a revenue of 179 million yuan, a year-on-year increase of 67.27%, while the net profit attributable to shareholders was a loss of 10 million yuan, a reduction in loss of 78.83% compared to the previous year [3]. - The gross profit margin for the first three quarters of 2024 was 87.58%, with a decrease of 2.41 percentage points year-on-year [6]. - The company’s operating expenses have decreased, with the sales expense ratio dropping by 9.64 percentage points to 49.23% [6]. Product Development - The company’s core product, Westgliptin, has been approved for new indications, which is expected to contribute to revenue growth [4]. - The company is expanding its product portfolio with new indications for Westgliptin, which is anticipated to enhance its market presence [4]. Future Projections - Revenue projections for the company are estimated to be 687 million yuan in 2024, with a growth rate of 31.16% [9]. - The net profit is expected to improve significantly by 2026, with a projected profit of 36 million yuan [9].
微芯生物(688321) - 投资者关系活动记录表2024年10月31日
2024-11-01 09:52
Group 1: Company Performance - The company achieved a revenue of 4.81 billion CNY in the first three quarters of 2024, representing a year-on-year growth of 16.73% [1] - Sales of Seglitazone increased by 38.02% year-on-year, while sales of Sidaprim showed a growth of 24.01% [1] - The company reported a revenue increase of 322.98% and a year-on-year growth of 414.65% [1] Group 2: Product Development - CS231295, a new drug for treating tumors, has shown significant preclinical efficacy and is currently under IND acceptance [2] - The company is focusing on developing innovative drugs that meet patient needs and have novel mechanisms of action [1] - The II phase clinical trial for Seglitazone in treating MASH has been selected for a presentation at the 2024 American Liver Meeting, indicating positive preliminary efficacy signals [2] Group 3: Strategic Partnerships and Market Position - The company has established a complete BD team for external cooperation and has maintained effective communication with various industry players [2] - Following the termination of the promotion authorization with Haizheng, the company plans to take over the marketing of Seglitazone in several provinces, enhancing its commercial strategy [3] - The company aims to leverage its own sales team and partnerships for specialized academic promotion of Seglitazone in mainland China [3] Group 4: Clinical Indicators and Regulatory Standards - Insulin resistance is identified as a core pathogenic factor in MASH, with the company focusing on improving clinical indicators related to liver fibrosis [2] - The recognized standard for MASH drug approval is improvement in liver fibrosis, with a focus on non-invasive methods for assessing liver fat [2] - In clinical trials, 51.6% of patients in the Seglitazone 64mg group showed a ≥30% reduction in liver fat after 18 weeks of treatment [2]
微芯生物:自愿披露关于西奥罗尼胶囊一线治疗广泛期小细胞肺癌获得药物临床试验批准通知书的公告
2024-11-01 09:28
证券代码:688321 证券简称:微芯生物 公告编号:2024-080 深圳微芯生物科技股份有限公司 自愿披露关于西奥罗尼胶囊一线治疗广泛期小细胞肺癌获 得药物临床试验批准通知书的公告 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。 深圳微芯生物科技股份有限公司(以下简称"公司")及全资子公司成都微 芯药业有限公司近日收到国家药品监督管理局(以下简称"国家药监局")签发的 境内生产药品注册临床试验的《药物临床试验批准通知书》,同意公司西奥罗尼 胶囊联合 PD-(L)1 单抗及化疗在广泛期小细胞肺癌一线治疗患者中开展临床试 验。现将相关情况公告如下: 一、药品基本情况 产品名称:西奥罗尼胶囊 受理号:CXHL2400869、CXHL2400870 适应症:联合 PD-(L)1 单抗及化疗一线治疗广泛期小细胞肺癌 申请人:深圳微芯生物科技股份有限公司、成都微芯药业有限公司 二、药品的其他相关情况 结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2024 年 8 月 27 日受理的西奥罗尼胶囊符合药品注册的有关要求,同 ...
微芯生物:关于召开2024年第三季度业绩说明会的公告
2024-10-30 10:54
证券代码:688321 证券简称:微芯生物 公告编号: 2024-079 深圳微芯生物科技股份有限公司 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: 投资者可于 2024 年 11 月 18 日(星期一)至 11 月 22 日(星期 五)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 ir@chipscreen.com 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。 财务总监:黎建勋先生 独立董事:罗勇根博士、黄民博士、王艳梅博士 深圳微芯生物科技股份有限公司(以下简称"公司")于 2024 年 10 月 31 日发布公司 2024 年第三季度报告,为便于广大投资者更全 面深入地了解公司 2024 年三季度的经营成果、研发进展,公司计划 于 2024 年 11 月 25 日上午 10:00-11:00 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 会议召开时间:2024 年 1 ...
微芯生物:第三届监事会第五次会议决议公告
2024-10-30 10:54
证券代码:688321 证券简称:微芯生物 公告编号:2024-078 深圳微芯生物科技股份有限公司 第三届监事会第五次会议决议公告 本公司监事会及全体监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。 一、监事会会议召开情况 深圳微芯生物科技股份有限公司(以下简称"公司")于 2024 年 10 月 30 日 以通讯方式召开了第三届监事会第五次会议(以下简称"本次会议")。本次的会 议通知于 2024 年 10 月 23 日通过电子邮件方式送达全体监事。会议应出席监事 3 人,实际出席监事 3 人,会议由公司监事会主席何杰先生主持。本次会议的召 集、召开程序和方式符合《公司法》等法律法规以及《公司章程》的有关规定, 会议决议合法、有效。 表决结果:同意 3 票,反对 0 票,弃权 0 票。 1 具体内容详见公司在上海证券交易所网站(www.sse.com.cn)披露的《2024 年第三季度报告》。 (二)审议通过《关于使用自有资金进行现金管理的议案》 为提高公司自有资金使用效率和收益,同意公司在保证不影响公司资金使用 和投资计划正常进行的前提 ...
微芯生物:第三届董事会第七次会议决议公告
2024-10-30 10:54
深圳微芯生物科技股份有限公司(以下简称"公司")于 2024 年 10 月 30 日 以现场及通讯相结合的方式召开第三届董事会第七次会议(以下简称"本次会 议")。本次的会议通知于 2024 年 10 月 23 日通过电子邮件方式送达全体董事。 会议应出席董事 8 人,实际到会董事 8 人,会议由公司董事长 XIANPING LU 先生 主持。会议的召集和召开程序符合《公司法》等法律法规以及《公司章程》的有 关规定,会议决议合法、有效。 二、董事会会议审议情况 证券代码:688321 证券简称:微芯生物 公告编号:2024-077 深圳微芯生物科技股份有限公司 第三届董事会第七次会议决议公告 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、准确性和完整性依法承担法律责任。 一、董事会会议召开情况 本议案已经董事会审计委员会审议通过,并同意提交董事会审议。 具体内容详见公司在上海证券交易所网站(www.sse.com.cn)披露的《2024 年第三季度报告》。 1 (二)审议通过《关于与海正药业签订<独占许可及联合营销战略合作协议 之终止协议>的议案》 同意 ...
微芯生物:关于与海正药业提前终止推广合作的公告
2024-10-30 10:54
证券代码:688321 证券简称:微芯生物 公告编号:2024-076 深圳微芯生物科技股份有限公司 关于与海正药业提前终止推广合作的公告 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。 重要内容提示: 原协议及终止协议主要内容: 随着公司西格列他钠片于2022年成功纳入国家医保目录以及公司自身销售 团队逐步成熟,为更好地落实公司协议产品下一发展阶段的产品商业化推广策略, 积极应对未来的市场竞争格局,经双方友好协商,并经公司第三届董事会第七次 会议审议通过,公司拟与海正药业签署《独占许可及联合营销战略合作协议之终 止协议》(以下简称"终止协议"),原协议自2024年10月31日(以下简称"终 止日")起终止,公司收回原协议约定的西格列他钠片在河南、浙江、江苏等19 个省份的独家市场推广权。公司销售团队将负责西格列他钠片在中国大陆地区的 全部推广活动。 按照《公司章程》等相关法律法规规定,本次终止独占许可及联合营销战略 合作协议已经公司第三届董事会第七次会议审议通过,公司与海正药业不存在关 联关系,亦不构成关联交易,无需提交 ...
微芯生物(688321) - 2024 Q3 - 季度财报
2024-10-30 10:54
Financial Performance - Operating revenue for Q3 2024 was ¥178,954,534.61, an increase of 67.27% compared to the same period last year[2] - Net profit attributable to shareholders was -¥10,078,540.92, with a year-to-date loss of -¥51,084,939.83, representing a decrease of 147.26% year-on-year[2] - Basic and diluted earnings per share for the year-to-date period were both -¥0.1252, reflecting a decrease of 147.26% year-on-year[2] - The net profit for Q3 2024 was -51,084,939.83 RMB, compared to a profit of 68,432,323.32 RMB in Q3 2023, representing a significant decline[18] - The total comprehensive income for Q3 2024 was -51,588,378.16 RMB, down from 70,373,533.42 RMB in the same period last year[19] - Basic and diluted earnings per share for Q3 2024 were both -0.1252 RMB, compared to 0.2649 RMB in Q3 2023[19] Cash Flow - Cash flow from operating activities for Q3 2024 was ¥59,016,488.83, a significant increase of 530.08% compared to the same period last year[2] - Cash flow from operating activities for the first three quarters of 2024 was 74,564,294.54 RMB, a recovery from -112,013,154.32 RMB in the same period last year[22] - Cash inflow from investment activities in Q3 2024 was 1,106,464,509.65 RMB, compared to 750,839,196.43 RMB in Q3 2023[22] - Cash outflow from investment activities totaled 1,386,493,392.38 RMB in Q3 2024, compared to 1,135,517,773.31 RMB in Q3 2023[22] - Cash flow from financing activities in Q3 2024 was 132,141,925.49 RMB, down from 339,051,069.70 RMB in Q3 2023[22] Assets and Liabilities - Total assets at the end of Q3 2024 were ¥3,338,141,167.42, an increase of 4.21% from the end of the previous year[3] - The company's total assets increased to CNY 3,338,141,167.42, compared to CNY 3,203,249,429.12 at the end of the previous year, reflecting a growth of about 4.2%[15] - The total liabilities of the company rose to CNY 1,694,830,204.04 from CNY 1,493,353,557.17, which is an increase of about 13.5%[15] - The company's cash and cash equivalents decreased to CNY 134,282,130.33 from CNY 216,717,350.00, representing a decline of approximately 38.2%[14] - Inventory levels increased slightly to CNY 49,417,728.34 from CNY 47,129,293.63, showing a growth of about 4.8%[14] - The total equity attributable to shareholders decreased to CNY 1,643,310,963.38 from CNY 1,709,895,871.95, reflecting a decline of approximately 3.9%[16] - Short-term borrowings decreased significantly to CNY 71,161,547.64 from CNY 130,112,786.24, indicating a reduction of about 45.3%[15] Research and Development - R&D expenses totaled ¥65,497,591.41, a decrease of 11.08% year-on-year, representing 36.60% of operating revenue, down 32.25 percentage points[3] - Research and development expenses for the first three quarters of 2024 were CNY 147,574,384.70, down from CNY 211,230,689.78 in the previous year, indicating a decrease of approximately 30.2%[17] Shareholder Information - The total number of common shareholders at the end of the reporting period is 18,601[9] - The largest shareholder, BGI Group, holds 34,705,162 shares, representing 8.51% of total shares[9] - The second-largest shareholder, Shenzhen Haiyue Men Biotechnology Development Co., Ltd., holds 22,936,008 shares, representing 5.62%[9] - The company had a total of 15,285,290 shares held by Shenzhen Haide Kangcheng Investment Partnership, representing 3.75% of total shares[12] - The company had no outstanding shares borrowed for margin trading at the end of the reporting period[11] - The company has a consistent shareholder structure with several entities having a unified action relationship[10] - The company had no changes in the number of shares held by major shareholders due to margin trading activities[12] Financial Reporting - The company’s financial statements are unaudited for the reporting period[13] - The company’s total assets and liabilities will be detailed in the upcoming financial reports[13] - Shenzhen Micu Biotechnology Co., Ltd. will implement new accounting standards starting in 2024, affecting the financial statements from the beginning of the year[23] - The company reported its Q3 2024 financial results on October 31, 2024[23] - The board of directors announced the adjustments related to the first-time execution of the new accounting standards[23] - No specific performance metrics or user data were disclosed in the report[23] - Future outlook and performance guidance were not provided in the document[23] - There were no mentions of new product or technology developments in the report[23] - Market expansion and acquisition strategies were not discussed in the content[23] - Other new strategies were not highlighted in the financial report[23] - The document does not contain specific financial figures or percentages related to performance[23] - The report is classified as not applicable for the new accounting standards implementation[23]