BOAN BIOTECH(06955)

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博安生物(06955) - 2024 - 中期业绩
2024-08-27 14:00
Financial Performance - For the six months ended June 30, 2024, the company's revenue was approximately RMB 362.9 million, an increase of about RMB 101.7 million or 38.9% compared to RMB 261.2 million for the same period in 2023, primarily driven by the continued sales growth of BA1101 and BA6101 in China [2]. - Gross profit for the six months ended June 30, 2024, was approximately RMB 282.6 million, an increase of about RMB 124.4 million or 78.6% compared to RMB 158.2 million for the same period in 2023 [2]. - The company recorded a profit before tax of RMB 61.7 million for the six months ended June 30, 2024, compared to a loss of RMB 119.3 million in the same period of 2023 [5]. - The basic and diluted earnings per share for the period were RMB 0.12, compared to a loss of RMB 0.23 per share in the same period of 2023 [5]. - The net profit for the six months ended June 30, 2024, was RMB 61.7 million, a significant improvement from a loss of RMB 119.5 million for the same period in 2023 [74]. Cost and Expenses - The cost of sales for the same period was RMB 80.3 million, representing approximately 22.1% of total revenue, a decrease from 39.4% in the previous year, attributed to increased production and upgraded manufacturing processes [2]. - Sales and distribution expenses increased to RMB 134.2 million, up RMB 17.1 million or 14.6% from RMB 117.1 million in the previous year, consistent with revenue growth [3]. - Research and development expenses decreased to approximately RMB 85.8 million, down RMB 40.2 million compared to RMB 126.0 million for the same period in 2023, mainly due to increased deferred development costs and more projects advancing to Phase III clinical trials [3]. - Administrative expenses decreased from RMB 26.6 million for the six months ended June 30, 2023, to RMB 24.3 million for the same period in 2024, primarily due to reduced professional consulting fees and improved management measures [69]. - Financial costs increased to RMB 12.6 million for the six months ended June 30, 2024, compared to RMB 6.3 million for the same period in 2023 [72]. Assets and Liabilities - Total assets as of June 30, 2024, were RMB 2,742.8 million, compared to RMB 2,283.4 million as of December 31, 2023, reflecting an increase in both non-current and current assets [6]. - The company's net assets increased to RMB 1,391.8 million as of June 30, 2024, from RMB 1,319.9 million as of December 31, 2023 [7]. - Trade receivables amounted to RMB 313,547,000 as of June 30, 2024, compared to RMB 213,199,000 as of December 31, 2023, representing a 47% increase [20]. - Trade payables totaled RMB 192,432,000 as of June 30, 2024, up from RMB 185,691,000 as of December 31, 2023, indicating a 4% increase [23]. - The debt-to-equity ratio increased from 30.0% as of December 31, 2023, to 47.0% as of June 30, 2024, primarily due to increased borrowings during the period [77]. Research and Development - The company focuses on the development of innovative biopharmaceuticals and biosimilars, with a product pipeline that includes multiple candidates with international intellectual property protection [33]. - The R&D team consists of 300 experienced members, and the company has been granted 36 patents and has 48 pending patent applications globally [35]. - The company has established a strong R&D platform focused on antibody discovery and drug development, with teams in China and the U.S. [51]. - BA5101, a long-acting GLP-1 receptor agonist, completed its Phase III clinical trial in China in March 2024 and received FDA approval for clinical trials in the US in August 2024 [42]. - BA1301, the first ADC targeting Claudin 18.2, has also entered Phase I clinical trials in China in 2023, with FDA granting ODD for gastric cancer and pancreatic cancer [49]. Market and Product Development - The company continues to focus on expanding its product offerings and enhancing its research and development capabilities to drive future growth [4]. - Three products (Boyuno®, Boyubei®, and Boluga®) successfully launched in mainland China, sold to over 2,700 targeted hospitals and institutions [34]. - The company is actively developing biopharmaceutical products in overseas markets, including the United States, the European Union, and Japan [33]. - The company aims to submit biologics license applications for BA6101 and BA1102 post Phase III trial completion in the US, Europe, and Japan [41]. - The company has granted exclusive commercialization rights for BA6101 to Qingdao Guoxin Pharmaceutical in mainland China [40]. Corporate Governance and Compliance - The company has adopted the corporate governance code as per the Hong Kong Stock Exchange's listing rules and has complied with all applicable provisions, with minor deviations noted [86]. - The audit committee has reviewed the accounting principles and policies adopted by the group and discussed the unaudited interim financial statements for the six months ended June 30, 2024 [90]. - The independent auditor has reviewed the interim financial information in accordance with the relevant standards, ensuring compliance with the Hong Kong Institute of Certified Public Accountants' guidelines [90]. Employee and Management - As of June 30, 2024, the group employed a total of 777 employees, an increase from 745 employees as of June 30, 2023 [82]. - Employee costs for the six months ended June 30, 2024, were approximately RMB 86.4 million, compared to RMB 85.1 million for the same period in 2023, reflecting a year-over-year increase of 1.5% [82]. - The total compensation for key management personnel was RMB 15,098,000 for the six months ended June 30, 2024, an increase from RMB 14,700,000 in the same period of 2023 [32].
博安生物(06955) - 2023 - 年度财报
2024-04-29 14:24
Financial Performance - For the year ended December 31, 2023, the company's revenue was approximately RMB 618.1 million, an increase of about RMB 102.1 million or 19.8% compared to RMB 516.0 million for the year ended December 31, 2022, primarily driven by sales growth of BA1101 and BA6101 in China [6]. - The gross profit for the year ended December 31, 2023, was approximately RMB 408.9 million, an increase of about RMB 54.7 million or 15.4% compared to the previous year [8]. - The net loss for the year was RMB 119.4 million, a significant reduction of 64.0% compared to the previous year [12]. - Revenue increased by 19.8% to RMB 618.1 million compared to 2022, demonstrating the ability to maintain market share in the biopharmaceutical sector [16]. - The company reported a total comprehensive loss of RMB 119,149,000 for the year, compared to RMB 330,046,000 in 2022, indicating improved overall performance [187]. Cost and Expenses - The cost of sales increased from RMB 161.7 million for the year ended December 31, 2022, to approximately RMB 209.2 million for the year ended December 31, 2023, representing about 33.9% of total revenue in the same year (2022: 31.3%) [7]. - Sales and distribution expenses for the year ended December 31, 2023, were RMB 256.5 million, an increase of RMB 42.4 million or 19.8% compared to RMB 214.1 million for the year ended December 31, 2022, consistent with revenue growth [9]. - Research and development expenses for the year ended December 31, 2023, were approximately RMB 230.7 million, a decrease of about RMB 169.6 million compared to RMB 400.3 million for the year ended December 31, 2022, mainly due to four R&D projects progressing to Phase III clinical trials [10]. - Administrative expenses decreased significantly from RMB 82.3 million for the year ended December 31, 2022, to RMB 51.7 million for the year ended December 31, 2023, due to reduced costs associated with the global offering [49]. Research and Development - The company has six projects in the pipeline, with BA1102 currently under BLA review in China and BA5101 and BA9101 having completed Phase III clinical trials [12]. - The company is actively expanding its product pipeline with multiple candidates in various stages of clinical development [22]. - The company has 29 innovative antibody and antibody-drug conjugate candidates, with 17 patents successfully granted and others pending [67]. - The company is committed to innovation, as evidenced by its ongoing patent applications for new therapeutic candidates [67]. Production and Capacity - The company is expanding its production capacity with multiple pilot and commercial production lines, enhancing scale efficiency [14]. - As of the report date, the company has a commercial production capacity of 9,000L and pilot production capacity of 700L, with multiple production lines under construction [18]. - The manufacturing base in Yantai covers approximately 84,474 square meters, with a total production capacity of 700L for pilot production and 9,000L for commercial production [33]. Market and Commercialization - The company has two commercialized products, with a strong focus on innovative antibody development across multiple therapeutic areas [15]. - Boyuno® has been included in the latest National Medical Insurance Drug List in China for all five indications as of December 2023 [16]. - The company has granted exclusive rights to Chengda Pharmaceutical (Qingdao) Co., Ltd. for the commercialization of Boyuno® in mainland China [16]. - The company aims to achieve profitability in the near term while focusing on becoming a leading global biopharmaceutical company in the long term [14]. Governance and Management - The company has a strong leadership team with extensive experience in the pharmaceutical industry, including over 35 years in accounting and auditing [70]. - The board consists of seven members, including two executive directors, two non-executive directors, and three independent non-executive directors as of December 31, 2023 [135]. - The company emphasizes the importance of independent oversight from its supervisors, with members having significant experience in finance and management [79]. - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value [133]. Financial Position - As of December 31, 2023, the company's cash and cash equivalents were RMB 201.9 million, a decrease of 13.5% from RMB 233.5 million as of December 31, 2022 [54]. - The company's total equity decreased to RMB 1,319,868,000 from RMB 1,418,377,000, reflecting a decline of 6.9% [190]. - The company’s total assets minus current liabilities stood at RMB 1,670,037,000, down from RMB 1,730,888,000 in 2022 [189]. - The company’s financial statements must be prepared in accordance with International Financial Reporting Standards and the Hong Kong Companies Ordinance [183]. Environmental and Social Responsibility - The company is committed to environmental sustainability and adheres to relevant environmental laws and regulations in China [93]. - The company promotes green measures and awareness in daily operations to fulfill its environmental protection commitments [93]. - The company encourages employee awareness of environmental protection and implements various green office measures [93]. Risks and Challenges - The company faces various risks that may impact its financial condition and operational performance, including market, operational, investment, and financial risks [87][88][90][92]. - The company has established risk management procedures to minimize significant risks that may affect its business objectives [92].
博安生物(06955) - 2023 - 年度业绩
2024-03-25 14:06
Financial Performance - For the year ended December 31, 2023, the company's revenue was approximately RMB 618.1 million, an increase of about RMB 102.1 million or 19.8% compared to RMB 516.0 million for the year ended December 31, 2022, primarily driven by sales growth of BA1101 and BA6101 in China [2]. - Gross profit for the year ended December 31, 2023, was approximately RMB 408.9 million, an increase of about RMB 54.7 million or 15.4% compared to RMB 354.2 million for the year ended December 31, 2022 [3]. - The company reported a pre-tax loss of RMB 119.4 million for the year ended December 31, 2023, compared to a pre-tax loss of RMB 331.7 million for the year ended December 31, 2022 [5]. - The company reported a net loss of RMB 119.4 million for the year ended December 31, 2023, compared to a net loss of RMB 331.7 million for the year ended December 31, 2022 [85]. - The total income from other income and gains was RMB 27,654 thousand in 2023, compared to RMB 24,348 thousand in 2022, showing an increase of approximately 9.5% [22]. - Administrative expenses significantly decreased from RMB 82.3 million for the year ended December 31, 2022, to RMB 51.7 million for the year ended December 31, 2023, due to a substantial portion of the previous year's expenses being related to global offering costs [80]. Cost and Expenses - The cost of sales increased from RMB 161.7 million for the year ended December 31, 2022, to approximately RMB 209.2 million for the year ended December 31, 2023, representing about 33.9% of total revenue in 2023, compared to 31.3% in 2022 [2]. - The company's selling and distribution expenses for the year ended December 31, 2023, were RMB 256.5 million, an increase of RMB 42.4 million or 19.8% compared to RMB 214.1 million for the year ended December 31, 2022 [3]. - Research and development expenses for the year ended December 31, 2023, were approximately RMB 230.7 million, a decrease from RMB 400.3 million for the year ended December 31, 2022, mainly due to the deferral of development costs for four R&D projects [3]. - Financial costs increased to RMB 14.1 million for the year ended December 31, 2023, from RMB 13.4 million in 2022, representing a growth of 5.2% [84]. Assets and Liabilities - Total assets as of December 31, 2023, were RMB 2,323.4 million, compared to RMB 2,202.6 million as of December 31, 2022 [6]. - The company's net assets decreased to RMB 1,319.9 million as of December 31, 2023, from RMB 1,418.4 million as of December 31, 2022 [7]. - Cash and cash equivalents decreased to RMB 201.9 million as of December 31, 2023, from RMB 233.5 million as of December 31, 2022 [6]. - The company had interest-bearing bank loans and other borrowings totaling approximately RMB 396.2 million as of December 31, 2023, an increase of RMB 102.9 million from RMB 293.3 million as of December 31, 2022 [87]. - As of December 31, 2023, the company's debt-to-equity ratio increased from 20.7% in 2022 to 30.0%, primarily due to an increase in short-term bank loans and other borrowings [88]. Market and Product Development - The company primarily engages in the development, manufacturing, and commercialization of high-quality biopharmaceutical products globally [9]. - Two commercialized products, BA1101 and BA6101, successfully launched in mainland China, with BA1101 included in the latest National Medical Insurance Drug List [41]. - BA1102's Biologics License Application (BLA) accepted in China, and Boyuno®'s BLA accepted in Brazil, indicating progress in international market expansion [42]. - The company has a commercial production capacity of 9,000L and pilot production capacity of 700L, with additional production lines under construction [44]. - The product portfolio includes two commercialized products, six innovative antibodies, and four candidate biologics, focusing on oncology, metabolism, autoimmune, and ophthalmology [46]. Research and Development - The R&D team consists of 303 experienced members, with 10 new patents granted and 4 international research papers published in 2023 [43]. - BA9101 completed patient enrollment in Phase III clinical trials in China, with significant progress in other pipeline products [42]. - The company has established an intelligent data environment to enhance production efficiency and ensure product quality and patient safety [44]. - The company has been granted 35 patents and has 45 pending patent applications globally, emphasizing the importance of intellectual property protection [63]. - The R&D capabilities are supported by proprietary platforms, including antibody discovery and ADC technology, enhancing the company's competitive edge [62]. Strategic Initiatives - The company aims for sustainable long-term growth through a diversified product portfolio and strong commercialization capabilities [40]. - The company plans to enhance its marketing capabilities by expanding sales and market teams and strengthening distribution channels to cover more target hospitals [70]. - The company intends to implement a clinical development strategy focused on innovative antibody drugs that address unmet medical needs in oncology [72]. - The company aims to explore collaborations with well-known partners in China and abroad to enhance market influence and facilitate clinical development and commercialization of early candidate drugs [75]. - The company has established market cooperation agreements with partners in several emerging market countries [45].
博安生物(06955)与兴业金租订立融资租赁协议
Zhi Tong Cai Jing· 2023-12-22 22:23
智通财经APP讯,博安生物(06955)公布,于2023年12月19日,该公司与兴业金租订立融资租赁协议,据 此,兴业金租将自该公司购买租赁资产并将于租赁期内向公司出租该租赁资产,惟可根据融资租赁协议 的条款及条件提早终止。 ...
博安生物(06955) - 2023 - 中期财报
2023-09-21 12:02
Product Development and Commercialization - Shandong Boan Biotechnology Co., Ltd. has successfully commercialized two products: BA1101, the third bevacizumab biosimilar approved in China, and BA6101, the world's first approved denosumab biosimilar for osteoporosis treatment[4] - The company has 11 candidate drugs nearing commercialization, including BA1102 for oncology, BA9101 for ophthalmology, and BA5101 for metabolic diseases, all in advanced clinical stages[4] - The commercial network has expanded to over 2,000 hospitals and institutions across China, demonstrating the company's robust commercialization capabilities[6] - Boan Biotechnology is actively pursuing international markets, with ongoing clinical trials for BA6101 and BA1102 in Europe, the United States, and Japan[4] - The company plans to submit multiple Biologics License Applications (BLA) for its candidate drugs within the next two years, indicating a strong pipeline for future growth[4] - The company has established a comprehensive biopharmaceutical platform covering the entire industry chain from R&D to commercialization, enhancing its operational efficiency[5] - Boan Biotechnology has formed strategic partnerships for product development and commercialization, including collaborations with Oconvision and Chengda Pharmaceutical[6] - The company focuses on innovative antibody development, with seven candidates in clinical stages, including BA1105 and BA1106 targeting solid tumors[4] - The company aims to leverage its differentiated product portfolio and strong commercialization capabilities to drive sustainable long-term growth[3] - The company successfully launched two products, BA1101 and BA1102, in mainland China, contributing to revenue growth[15] - BA1101 received two new indications included in the updated National Medical Insurance Drug List in January 2023, which is expected to drive continued sales growth[15] - The company granted exclusive commercialization rights for BA1102 to Chia Tai Tianqing Pharmaceutical (Qingdao) Co., Ltd., enhancing its market presence[15] - The company focuses on a comprehensive range of biopharmaceuticals, including innovative biologics and biosimilars, with ongoing development in international markets such as the US, EU, and Japan[14] - The company has achieved significant progress in clinical trials, with five candidate products in Phase III trials and four products entering Phase I trials[16] - The company has initiated international multicenter Phase III clinical studies for BA6101 and BA1102, with the first patient enrolled in May 2023[16] - The company has developed a balanced product portfolio aimed at achieving commercialization in the short term and driving sustainable long-term growth[18] Financial Performance - The company's revenue for the six months ended June 30, 2023, was approximately RMB 261.2 million, an increase of about RMB 40.5 million or 18.4% compared to RMB 220.7 million for the same period in 2022[9] - The cost of sales for the same period was RMB 103.0 million, accounting for approximately 39.4% of total revenue, up from 33.3% in the previous year, primarily due to a decrease in production volume leading to higher unit manufacturing costs[10] - Gross profit for the six months ended June 30, 2023, was approximately RMB 158.2 million, a decrease of about RMB 10.9 million or 7.4% compared to the same period in 2022[11] - Sales and distribution expenses increased to approximately RMB 117.1 million, up RMB 16.3 million or 16.2% from RMB 100.8 million in the prior year, consistent with revenue growth[12] - Research and development expenses were approximately RMB 126.0 million, a decrease of about RMB 43.1 million, mainly due to one R&D project progressing to Phase III clinical trials[13] - The company reported a total comprehensive loss of RMB 119,078,000 for the period, compared to RMB 152,218,000 in the previous year, showing a 21.8% improvement[74] - The net loss for the six months ended June 30, 2023, was RMB 119.5 million, compared to RMB 153.3 million for the same period in 2022[47] - Cash and cash equivalents increased by RMB 16.5 million to RMB 250.0 million as of June 30, 2023, representing a year-on-year growth of 7.1%[47] - Current assets decreased by RMB 234.9 million to approximately RMB 140.1 million as of June 30, 2023, reflecting a year-on-year decline of 62.6%[47] - The debt-to-asset ratio increased from 20.7% as of December 31, 2022, to 21.9% as of June 30, 2023, primarily due to a decrease in reserves during the period[51] - The total capital commitments for the acquisition of property, plant, and equipment amounted to RMB 212.2 million as of June 30, 2023[52] - The employee cost for the six months ended June 30, 2023, was approximately RMB 85.1 million, compared to RMB 68.4 million for the same period in 2022[53] - The company reported a pre-tax loss of RMB 119,274,000, an improvement from a loss of RMB 153,295,000 in the previous year[74] - The company’s total liabilities increased to RMB 833,644,000, up from RMB 743,342,000, indicating a rise of 12.2%[75] - The company’s total equity decreased to RMB 1,309,534,000 from RMB 1,418,377,000, reflecting a decline of 7.7%[77] Research and Development - As of June 30, 2023, the R&D team consists of 285 experienced members, covering various research functions[16] - The company has obtained seven new patents and published two new international research papers since the beginning of 2023[16] - The company has established a strategic cooperation agreement with 金斯瑞生物科技股份有限公司 to enhance the R&D efficiency of its cell therapy product platforms[32] - The company will continue to enrich its innovative antibody pipeline by developing strategically selected antibody targets with significant market potential[36] - Research and development for the group's core products is expected to utilize approximately RMB 91 million by December 31, 2024[58] - Research and development for other products in the pipeline is expected to utilize approximately RMB 48 million by December 31, 2024[58] Market Strategy and Expansion - The company aims to enhance its marketing capabilities and expand its sales and distribution network to cover more target hospitals, thereby increasing the market share of BA1101[34] - The company plans to explore collaborations with well-known international partners to enhance its overseas influence and expand geographical coverage for its candidate drugs[38] - The company aims to leverage its strong commercialization capabilities and partnerships to accelerate the market potential of its products[29] - The company has a network of approximately 200 distributors, reaching over 1,900 target hospitals and institutions in selected regions of China[29] Corporate Governance and Compliance - The company has adhered to all applicable corporate governance code provisions, with one exception regarding the separation of the roles of Chairman and CEO[60] - The audit committee reviewed the unaudited interim financial statements for the six months ended June 30, 2023, and recommended their adoption to the board[62] - The company has not conducted any equity fundraising activities during the reporting period[59] - The company did not declare any interim dividends for the six months ended June 30, 2023, consistent with the previous year[99] Miscellaneous - The company was included in the Stock Connect program on March 13, 2023, indicating compliance with higher standards in revenue and market capitalization[16] - The company has not purchased, sold, or redeemed any of its listed securities during the six months ended June 30, 2023[62] - The company has no financial liabilities measured at fair value as of June 30, 2023[120]
博安生物(06955) - 2023 - 中期业绩
2023-08-27 10:29
Financial Performance - For the six months ended June 30, 2023, the company's revenue was approximately RMB 261.2 million, an increase of about RMB 40.5 million or 18.4% compared to RMB 220.7 million for the same period in 2022, primarily driven by the continued sales growth of BA1101 in China[2]. - Gross profit for the six months ended June 30, 2023, was approximately RMB 158.2 million, a decrease of about RMB 10.9 million or 7.4% compared to RMB 147.3 million for the same period in 2022[2]. - The company reported a loss before tax of RMB 119.3 million for the six months ended June 30, 2023, compared to a loss of RMB 153.3 million for the same period in 2022[5]. - Basic and diluted loss per share for the period was RMB 0.23, compared to RMB 0.31 for the same period in 2022[5]. - The company reported a basic loss per share of RMB 0.51, calculated based on a weighted average of 509,278,094 shares issued during the period[23]. - The company reported a loss of RMB 119.5 million for the six months ended June 30, 2023, compared to a loss of RMB 153.3 million for the same period in 2022[74]. Cost and Expenses - The cost of sales for the same period was RMB 103.0 million, accounting for approximately 39.4% of total revenue, up from 33.3% in the same period of 2022, due to a decrease in production volume leading to higher unit manufacturing costs[2]. - Selling and distribution expenses were approximately RMB 117.1 million, an increase of RMB 16.3 million or 16.2% compared to RMB 100.8 million for the same period in 2022, consistent with revenue growth[3]. - Research and development expenses were approximately RMB 126.0 million, a decrease of about RMB 43.1 million compared to RMB 169.1 million for the same period in 2022, mainly due to the advancement of a research project to Phase III clinical trials[3]. - Administrative expenses significantly decreased from RMB 37.6 million for the six months ended June 30, 2022, to RMB 26.6 million for the same period in 2023, primarily due to the absence of listing-related expenses[69]. - Other income and gains decreased to RMB 1.7 million, down approximately RMB 11.8 million or 87.4% from RMB 13.5 million in the prior year, mainly due to a reduction in government grants[68]. Assets and Liabilities - Total non-current assets as of June 30, 2023, were RMB 1,475.1 million, an increase from RMB 1,355.9 million as of December 31, 2022[6]. - Current assets totaled RMB 668.1 million as of June 30, 2023, down from RMB 846.7 million as of December 31, 2022[6]. - The company's net assets were RMB 1,309.5 million as of June 30, 2023, compared to RMB 1,418.4 million as of December 31, 2022[7]. - The total non-current liabilities increased by RMB 239 thousand due to the recognition of deferred tax liabilities related to leasing transactions[12]. - The total equity decreased by RMB 239 thousand as a result of the cumulative losses recognized in the financial statements[13]. - As of June 30, 2023, the group's debt-to-equity ratio increased from 20.7% as of December 31, 2022, to 21.9% as of June 30, 2023, primarily due to a decrease in reserves during the period[77]. Research and Development - As of June 30, 2023, the R&D team consists of 285 experienced members, and the company has obtained 7 new patents globally[38]. - The company continues to focus on R&D capabilities and industry influence, with significant advancements in its innovative product pipeline[38]. - The company aims to enhance its innovative antibody pipeline by focusing on the development of novel antibody drugs that address unmet medical needs, particularly in oncology[61]. - The company is committed to maintaining high standards in clinical research and regulatory compliance to ensure successful product launches[42]. - The company plans to invest in manufacturing equipment to expand production capacity, including two production lines with three 2,000-liter single-use bioreactors each[63]. Market and Product Development - Two products, Boanuo® and Boanubei®, have successfully launched in mainland China, with Boanuo® gaining two new indications included in the updated National Medical Insurance Catalog[37]. - The company has a balanced product pipeline, including two commercialized products and seven innovative research antibodies, targeting major therapeutic areas with substantial unmet market demand[40]. - The company is actively pursuing international market expansion, with applications for product approvals in Brazil and other regions[42]. - The company anticipates launching four candidate products (BA1102, BA5101, BA9101, and BA1104) in the Chinese market within the next three years, with three products (博优诺®, BA6101, and BA1102) expected to launch internationally[61]. - The collaboration with Eucan Vision for BA9101 aims to accelerate clinical trials and commercialization in China[44]. Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes during the reporting period, with one exception regarding the separation of roles between the Chairman and CEO[89]. - The company maintains high standards of corporate governance to protect shareholder interests and enhance corporate value[88]. - The independent auditor has reviewed the unaudited interim financial statements for the six months ending June 30, 2023[92].
博安生物(06955) - 2022 - 年度财报
2023-04-25 14:47
Product Development and Commercialization - Shandong Boan Biotechnology has successfully commercialized two products: BA1101, a biosimilar to Bevacizumab, and BA6101, the world's first biosimilar to Denosumab[4]. - The company has 11 candidate drugs nearing commercialization, including BA1102 and BA9101, which are in the late stages of clinical trials[4]. - The company plans to submit multiple Biologics License Applications (BLA) for its candidate drugs in the next two years[4]. - BA1102 and BA6101 are also in preparation for clinical trials overseas, indicating the company's international expansion efforts[4]. - The company aims to accelerate the market entry of its drugs through a diversified commercialization strategy, including domestic and international markets[7]. - The company has formed strategic partnerships with companies like AstraZeneca and Zhengda Pharmaceutical to enhance product commercialization[7]. - The company has a robust product pipeline with two commercialized products, seven innovative antibodies, and four biosimilar candidates[21]. - BA1102, a biosimilar drug, has completed Phase III clinical trials and is currently under BLA submission in China[22]. - The company is actively pursuing business collaborations to expand its market presence and enhance its innovative product offerings[20]. - The company is focusing on expanding its market presence in Europe and the US for its biosimilar products, aiming for global sales[28]. Financial Performance - The company's revenue for the year ended December 31, 2022, reached approximately RMB 516.0 million, a significant increase of 225.1% compared to RMB 158.7 million for the year ended December 31, 2021[10]. - Gross profit for the same period was approximately RMB 354.2 million, representing a year-on-year increase of 232.6%[12]. - The company recorded a net loss of RMB 331.7 million for the year ended December 31, 2022, compared to a net loss of RMB 240.5 million in 2020[15]. - The company's total equity decreased to RMB 1,418,377,000 from RMB 1,551,687,000, reflecting a decline in shareholder value[179]. - The company reported a total revenue of RMB 515,960,000 for 2022, a significant increase of 225.5% compared to RMB 158,704,000 in 2021[177]. - The net loss attributable to the owners of the parent company was RMB 331,749,000, compared to a loss of RMB 225,417,000 in 2021, indicating a worsening financial performance[177]. Research and Development - Research and development expenses totaled approximately RMB 400.3 million, up by RMB 168.7 million from RMB 231.6 million in 2021, driven by increased investment in R&D projects[14]. - The company has expanded its R&D team to 285 members and secured 21 new patents globally as of December 31, 2022[23]. - The company’s ongoing research and development efforts are aimed at enhancing its product pipeline across various therapeutic areas, including oncology and autoimmune diseases[28]. - The company has established a comprehensive biopharmaceutical platform that integrates R&D, production, and commercialization, enhancing operational efficiency[6]. Market Strategy and Distribution - Shandong Boan Biotechnology's distribution network covers over 1,000 hospitals nationwide, demonstrating its strong commercialization capabilities[7]. - The company anticipates 2023 to be a year of significant revenue growth from commercialized products and accelerated innovation pipeline development[20]. - The company has made significant progress in obtaining medical insurance access for its products, which is expected to drive sustained sales growth[22]. - The company has established a customer complaint handling mechanism to enhance service quality[98]. Corporate Governance and Management - The company has a board composed of experienced members, including the CEO and R&D President, with over 24 years of experience in the pharmaceutical industry[68][69]. - The company has adopted a set of corporate governance standards that meet or exceed the standard code[5]. - The board consists of nine members, including two executive directors, three non-executive directors, and three independent non-executive directors[130]. - The company has established five board committees: Audit Committee, Remuneration Committee, Nomination Committee, Strategic Committee, and Environmental, Social and Governance Committee[129]. - The company emphasizes the importance of diverse experiences and skills among board members for effective governance[132]. Financial Management and Risk Assessment - The company has implemented risk management procedures to minimize financial risks, including interest rate, foreign exchange, credit, and liquidity risks[96]. - The company has established a framework for investment risk assessment to balance various investment risks and returns[94]. - The company has established clear responsibilities and powers within its organizational structure to ensure effective risk management and internal controls[154]. - The company has a policy for reviewing and monitoring compliance with legal and regulatory requirements[142]. Environmental and Social Responsibility - The company is committed to environmental sustainability and adheres to relevant environmental laws and regulations in China[97]. - The company encourages green practices and promotes environmental awareness among employees[97]. - The Environmental, Social, and Governance (ESG) Committee was established on March 27, 2023, to manage ESG-related risks and opportunities[152]. Employee and Shareholder Relations - The company employed a total of 745 employees as of December 31, 2022, up from 572 employees as of December 31, 2021, with employee costs amounting to RMB 121.4 million in 2022[65]. - The company has a commitment to independent oversight, as evidenced by the diverse backgrounds of its board members in various sectors[82]. - The company has established a shareholder communication policy to facilitate ongoing dialogue and information sharing with investors[159].
博安生物(06955) - 2022 - 年度业绩
2023-03-27 14:44
Financial Performance - For the year ended December 31, 2022, the company's revenue was approximately RMB 516.0 million, an increase of about RMB 357.3 million or 225.1% compared to RMB 158.7 million for the year ended December 31, 2021[2]. - Gross profit for the year ended December 31, 2022, was approximately RMB 354.2 million, representing a year-on-year increase of about RMB 247.7 million or 232.6%[3]. - The company reported a pre-tax loss of RMB 331.7 million for the year ended December 31, 2022, compared to a loss of RMB 225.4 million for the year ended December 31, 2021[4]. - The company reported a net loss of RMB 331.7 million for the year ended December 31, 2022, compared to a loss of RMB 225.4 million in 2021[79]. - The effective tax rate for the company was reduced to 15% in 2022 from 25% in 2021 due to its recognition as a high-tech enterprise[28]. Expenses - The cost of sales increased from RMB 52.2 million for the year ended December 31, 2021, to approximately RMB 161.7 million for the year ended December 31, 2022, accounting for about 31.3% of total revenue in 2022 (2021: 32.9%) due to increased production volume[2]. - Research and development expenses for the year ended December 31, 2022, amounted to approximately RMB 400.3 million, an increase of about RMB 168.7 million compared to RMB 231.6 million for the year ended December 31, 2021, primarily due to increased investment in R&D projects[4]. - Selling and distribution expenses rose to RMB 214.1 million for the year ended December 31, 2022, an increase of RMB 54.0 million or 296.5% compared to RMB 160.1 million for the year ended December 31, 2021[3]. - Administrative expenses increased significantly from RMB 42.2 million in 2021 to RMB 82.3 million in 2022, primarily due to global sales listing expenses rising from RMB 2.4 million to RMB 43.1 million[74]. - Financing costs rose to RMB 13.4 million in 2022, up from RMB 11.6 million in 2021, representing a 15.5% increase due to higher bank loan levels[78]. Assets and Liabilities - Total non-current assets as of December 31, 2022, were approximately RMB 1,355.9 million, an increase from RMB 1,166.8 million as of December 31, 2021[6]. - Current assets decreased to RMB 846.7 million as of December 31, 2022, from RMB 939.9 million as of December 31, 2021[6]. - The company's total liabilities increased to RMB 471.7 million as of December 31, 2022, compared to RMB 260.5 million as of December 31, 2021[6]. - Net assets decreased to RMB 1,418.4 million as of December 31, 2022, from RMB 1,551.7 million as of December 31, 2021[7]. - Total equity as of December 31, 2022, was CNY 1,418,377, a decrease from CNY 1,551,687 in the previous year, representing a decline of approximately 8.6%[8]. Revenue Sources - Total revenue from customer contracts for 2022 was RMB 515,960,000, a significant increase from RMB 158,704,000 in 2021, representing a growth of approximately 225%[19]. - Major customer A contributed RMB 191,396,000 to the revenue in 2022, up from RMB 48,291,000 in 2021, indicating a growth of 296%[18]. - All external revenue for the year was generated from customers in mainland China, indicating a focused market strategy[20]. Research and Development - The company has developed a diverse and risk-balanced product pipeline, including two commercialized products, seven innovative antibodies, and four candidate biosimilars, focusing on major therapeutic areas such as oncology, metabolism, autoimmune diseases, and ophthalmology[45]. - As of December 31, 2022, the R&D team comprised 285 experienced members, contributing to the filing of 21 new patents and the publication of 7 research papers[44]. - The company has established a mature proprietary R&D platform focused on antibody discovery and drug development, with teams in Yantai, Nanjing, and Boston[57]. Product Development and Commercialization - The company has successfully launched two products, BA1101 and BA6101, in mainland China[43]. - The commercialized product, Boyounuo® (Bevacizumab injection), received approval from the National Medical Products Administration (NMPA) in April 2021 and has expanded its indications to include multiple cancers, enhancing its market accessibility[47]. - Boyoubai® (Duzhong antibody injection), the first biosimilar of Prolia®, was approved in November 2022 for treating postmenopausal women at high risk of fractures, significantly reducing fracture risks in this population[48]. - BA1102 received acceptance for the biopharmaceutical license application in China in March 2023, with ongoing R&D in Europe and the US, aiming for global market sales[49]. Market Strategy and Future Outlook - The company emphasizes the unmet market demand in China and abroad for its therapeutic areas, which could drive future growth[45]. - The company plans to enhance its commercialization capabilities by expanding sales and marketing teams to cover more target hospitals, aiming to increase the market share of its product 博優諾®[64]. - The company seeks to explore collaborations with renowned international partners to enhance its overseas influence and expand geographical coverage for its candidate drugs[68].