CANSINOBIO(06185)
Search documents
康希诺生物(06185) - 2019 - 年度财报

2020-04-08 10:01
Financial Performance - In 2019, the company reported a revenue of RMB 1,132 million, marking a significant increase from previous years[22] - The operating loss for 2019 was RMB 200,245 thousand, compared to RMB 138,578 thousand in 2018, indicating a worsening financial performance[22] - The total assets of the company reached RMB 1,784,498 thousand in 2019, a substantial increase from RMB 795,875 thousand in 2018[23] - The company’s total equity rose to RMB 1,470,516 thousand in 2019, up from RMB 502,317 thousand in 2018, reflecting improved financial stability[23] - The company’s basic and diluted loss per share for 2019 was RMB 0.77, slightly improved from RMB 0.90 in 2018[22] - The company reported no revenue for the year ended December 31, 2019, compared to RMB 1.1 million in revenue from R&D services in the previous year[52] - Other income decreased slightly from RMB 20.0 million in 2018 to RMB 19.0 million in 2019, primarily from government grants and investment income[53] - Research and development expenses increased by 33.5% to RMB 151.7 million for the year ended December 31, 2019, driven by higher employee benefits and depreciation costs[56] - Financial income net increased significantly from RMB 0.3 million in 2018 to RMB 43.5 million in 2019, mainly due to increased interest income from bank deposits[58] - The company anticipates continued losses in the coming years and may require significant additional financing to support operations[174] Vaccine Development and Clinical Trials - The company is actively pursuing the development of a COVID-19 vaccine, with clinical trials currently underway for a recombinant adenovirus vaccine[25] - The company is developing 16 vaccine candidates across 13 disease areas, with three nearing commercialization, including MCV4 and Ad5-EBOV[26] - MCV4 has received priority review from the National Medical Products Administration (NMPA) and is designed to cover a broader age range, from 3 months to 6 years, compared to existing vaccines[31] - The clinical trial for MCV2 has shown better safety and immunogenicity in infants aged 6 to 23 months compared to currently approved MCV2 products in China[32] - Ad5-EBOV is the first approved Ebola vaccine in China for emergency use, with a recommended dosage of one dose containing 8.0×10^10 viral particles[33] - The company has not yet commercialized any products and cannot guarantee the successful development and commercialization of its vaccine candidates[26] - The company has completed the clinical trial report for MCV4 and expects to conduct pre-licensing inspections in 2020[31] - The company has made improvements in the design and production process of the PCV13i vaccine, which is intended to compete with existing global standards[29] - The company has received clinical trial approval for Ad5-nCoV, a recombinant COVID-19 vaccine, in March 2020[30] - The company aims to replace mainstream vaccines in China with higher quality, world-class vaccines through its innovative pipeline[26] - The company is developing a potential best-in-class DTcP vaccine for infants, which contains three pertussis antigens compared to the two in the only existing DTcP vaccine in China, aiming for better protection[34] - The company has received clinical trial approval for the DTcP booster vaccine and has initiated Phase I trials in China, expecting to complete all clinical trials by 2021 or earlier[35] - The adolescent and adult Tdcp vaccine is being developed to compete with world-class vaccines like Boostrix and Adacel, with plans to submit a clinical trial application in China by the end of 2020[36] - The innovative PBPV vaccine aims to provide broader coverage against over 90 serotypes of pneumonia, with Phase I trials expected to be completed by 2020[37] - The company has received approval for the clinical trial of the improved PCV13i vaccine and has started Phase I trials, anticipating completion of Phase III trials by 2022[38] - The Ad5-nCoV vaccine, developed in collaboration with the Military Medical Research Institute, has entered clinical trials to prevent COVID-19[39] - The company is developing a tuberculosis booster vaccine, with plans to submit a clinical trial application based on positive Phase I results, expecting to start Phase II trials in 2020[41] - Six vaccine candidates are in preclinical plans, including a combined DTcP-Hib vaccine, with submissions for clinical trial approvals expected in 2020[42][43] - The company aims to develop a new shingles vaccine utilizing its viral vector platform technology, with plans to request a pre-application meeting for clinical trials in 2020[44] - The company has developed a meningitis B vaccine to address the unmet medical need as serogroup B has become the leading cause of meningitis in China[45] - The global demand for inactivated polio vaccine (IPV) has surged, leading to a supply shortage, and the company aims to develop IPV to compete with major vaccines[46] Corporate Governance - The company has adopted all applicable provisions of the corporate governance code as per the listing rules[85] - The company is committed to maintaining high levels of corporate governance to protect shareholder rights and enhance corporate value[85] - The board consists of four executive directors, four non-executive directors, and four independent non-executive directors[87] - The company has confirmed that all directors and supervisors complied with the standard code for securities trading during the reporting period[86] - The management team includes experienced professionals with backgrounds in investment management and corporate strategy[83] - The company has established a nomination policy to ensure diversity and appropriate qualifications among board members[90] - Independent non-executive directors are responsible for ensuring high levels of regulatory reporting and providing independent judgment on corporate actions[91] - The company provides liability insurance for directors and senior management against legal actions taken in relation to company affairs[92] - The board is committed to continuous professional development for all directors to ensure they remain informed and effective[92] - The company has a structured approach to evaluating the skills and experience required for board vacancies[90] - The board's overall strategy and major business policies are developed through in-depth discussions between the board and senior management[88] - The company has established a Compensation and Assessment Committee to review and recommend compensation policies for directors and senior management[96] - The company’s governance policies include considerations for board diversity, including gender, age, cultural background, and professional qualifications[97] - The audit committee held three meetings during the reporting period, reviewing interim performance and financial reporting procedures[94] - The audit committee is responsible for overseeing the company's financial reporting processes and internal control systems[94] - The board believes that the current governance structure, with the CEO also serving as the chairman, is beneficial for the company's operational efficiency[88] - The company has established a risk management and internal control system aimed at managing risks associated with achieving business objectives, providing reasonable assurance against significant misstatements or losses[101] - The audit committee assists the board in overseeing the design, implementation, and monitoring of the risk management and internal control systems, with regular assessments conducted by various departments[101] Environmental, Social, and Governance (ESG) Performance - The company has committed to transparency in its environmental, social, and governance (ESG) performance, adhering to the ESG reporting guidelines[111] - The reporting period for the ESG report covers January 1, 2019, to December 31, 2019, focusing on the company's main production and operational locations in Tianjin, China[112] - The company ensures the accuracy and completeness of the report's content, taking responsibility for any misleading statements[113] - The total energy consumption for 2019 was 38,144.88 MWh, with direct energy consumption from natural gas at 23,574.88 MWh and indirect energy consumption from electricity at 14,570.00 MWh[120] - The total water consumption for 2019 was 229,196.00 tons, with a per unit floor water consumption of 44.94 tons per square meter[120] - The company has not experienced any major violations of Chinese environmental laws and regulations during the reporting period[118] - The company has established an environmental management system that includes chemical usage and management, waste disposal, and laboratory waste handling[118] - The company aims to enhance resource utilization efficiency through lean management and green office initiatives[119] - The company has identified key ESG issues such as product responsibility and employment, with significant concerns including environmental management and health and safety[115] - The company received multiple honors, including being recognized as a national high-tech enterprise and one of the top 100 innovative pharmaceutical companies in China[117] - The company has a dedicated Environment, Health, and Safety (EHS) department to oversee overall environmental management and compliance[118] - The company promotes energy-saving measures and has optimized the use of steam generators and air conditioning systems to improve energy efficiency[119] - The company has implemented measures to reduce gas emissions and improve natural gas usage efficiency to minimize environmental impact[121] - Total greenhouse gas emissions in 2019 amounted to 14,996.70 tons of CO2 equivalent, with direct emissions from natural gas at 4,609.75 tons and indirect emissions from electricity at 10,386.95 tons[123] - The total amount of hazardous waste generated was 44.46 tons, while non-hazardous waste amounted to 33.25 tons in 2019[123] - The company has established a competitive compensation and benefits system, including stock incentives and annual performance bonuses[133] - The company has implemented a hazardous waste management system, ensuring proper collection, classification, and treatment of hazardous waste[124] - The company has a performance management system in place, conducting annual comprehensive performance evaluations for employees[135] - The company organized a family day event in October 2019, attended by over 600 employees and their family members, promoting work-life balance[140] - The company emphasizes a systematic safety management system, including regular safety training and emergency drills, ensuring compliance with national safety regulations[142] - During the reporting period, the company did not experience any employee injuries or fatalities[143] - The company provided an average of 23 hours of training per employee during the reporting period, covering all staff[149] Research and Development - The company is currently engaged in R&D activities, with a focus on developing innovative and affordable vaccines[171] - The company's R&D expenses totaled approximately RMB 152 million during the reporting period[159] - The internal R&D team consists of 136 employees, with 68.4% holding a graduate degree or higher and 97.8% holding a bachelor's degree or higher[159] - The company has established four major platform technologies for vaccine development, including polysaccharide-protein conjugate technology and adenovirus vector vaccine technology[159] - The company signed a collaboration agreement with BRID-C in 2019 to explore bacterial ghosts as an independent adjuvant for vaccines[159] - The company obtained 10 new invention patents during the reporting period, including 4 newly authorized patents and 6 transferred authorized patents[160] - As of the end of the reporting period, the company holds 59 trademarks, including 33 in China and 1 in the United States[161] - The company has implemented strict data protection measures, including encrypted management of all office documents to prevent information leakage[162] - No significant incidents of data leakage, theft, or loss of customer and trial participant information occurred during the reporting period[162] Employee Engagement and Community Involvement - The company employed a total of 429 staff members and 8 consultants as of the end of the reporting period[125] - The company expanded its campus recruitment activities to multiple provinces, engaging with 17 universities across seven cities during the 2019 autumn recruitment[132] - The company initiated the "Monthly Star" program in June 2019, recognizing 224 employees for outstanding performance during the reporting period[134] - The company engages with local communities to identify public welfare needs and organizes educational activities related to pharmaceuticals and biological sciences[165] - A dedicated vaccine knowledge exhibition hall was established to promote scientific knowledge among students and social groups[165] - The company actively participates in industry exchanges and shares vaccine knowledge and research findings at various conferences[166] Risk Management and Compliance - The company has established a risk management and internal control system aimed at managing risks associated with achieving business objectives, providing reasonable assurance against significant misstatements or losses[101] - The audit committee assists the board in overseeing the design, implementation, and monitoring of the risk management and internal control systems, with regular assessments conducted by various departments[101] - The company has implemented internal regulations to manage ethical risks during procurement and encourages suppliers to report fraudulent activities[164] - An online and offline complaint channel is established for reporting corruption, ensuring the protection of whistleblower privacy[164] - The company has a "Corruption Blacklist" to monitor suppliers with significant violations and restrict or terminate cooperation with them[164] Market Competition and Challenges - The company has faced significant competition in the vaccine market and may struggle to maintain profitability[175] - The company has identified risks related to regulatory approvals for its vaccine candidates, which may impact future commercialization efforts[175] - The outbreak of COVID-19 may affect the company's operations, including clinical trials and regulatory inspections[176]
康希诺生物(06185) - 2019 - 中期财报

2019-09-19 08:40
Financial Performance - For the six months ended June 30, 2019, the company reported a revenue of RMB 0 thousand, indicating no revenue generation during this period [20]. - The operating loss for the same period was RMB 88,586 thousand, an increase of 71.8% compared to the previous year's loss of RMB 51,557 thousand [20]. - The loss before income tax was RMB 69,677 thousand, which is a 35.3% increase from RMB 51,481 thousand in the prior year [20]. - The total comprehensive loss for the period was RMB 69,677 thousand, reflecting the same percentage increase as the loss before income tax [20]. - The basic and diluted loss per share was RMB 0.38, which is an increase of 11.8% from RMB 0.34 in the previous year [20]. - The company reported a net loss of RMB 69.68 million for the first half of 2019, compared to a loss of RMB 51.48 million in the same period of 2018, representing a 35.3% increase in losses year-over-year [84]. - The company reported a gross operating loss of RMB 88.59 million for the first half of 2019, compared to a loss of RMB 51.56 million in the same period of 2018 [84]. - Other income decreased to RMB 5.39 million in 2019 from RMB 9.96 million in 2018, a decline of 46.1% [84]. - Financial income increased significantly to RMB 19.41 million in 2019 from RMB 0.12 million in 2018 [84]. - The company reported a cumulative loss of RMB (280,965) thousand as of June 30, 2019, compared to RMB (211,288) thousand in the previous year [87]. Research and Development - The company is developing 15 vaccine candidates across 12 disease areas, with three nearing commercialization [21]. - Six vaccine candidates are currently in clinical trial phases, while six others are in preclinical development, including a combined vaccine [21]. - The company's mission focuses on developing high-quality, innovative, and affordable vaccines to meet unmet medical needs in China [21]. - The product pipeline includes potential global innovative vaccines and vaccines aimed at replacing existing mainstream vaccines in China [21]. - The company has not yet commercialized any products and cannot guarantee successful development and commercialization of its vaccine candidates [21]. - The company plans to submit new drug applications for its vaccine candidates by the end of 2019 [153]. - CanSino Biologics has established partnerships with several international organizations to facilitate research and development of new vaccines [153]. - The company has allocated RMB 300 million for research and development in 2019, which is a 15% increase compared to the previous year [153]. Vaccine Development and Trials - PCV13i clinical trial application approved on April 19, 2019, aimed to compete with the world-class PCV13 product for children under 2 years old [24]. - MCV4 new drug application pre-meeting submitted to the National Medical Products Administration on July 5, 2019, potentially being the first MCV4 new drug application in China [24]. - MCV4 demonstrated good safety and immunogenicity in children aged 3 months to 6 years, covering a broader range of serogroups compared to existing products [24]. - The company completed the III phase clinical trial for MCV4 and expects to submit the new drug application soon based on the response from the National Medical Products Administration [25]. - The company anticipates conducting pre-licensing inspections for MCV4 in 2020, followed by its market launch [25]. - The in-development MCV2 vaccine shows better safety and immunogenicity in the 6 to 23 months age group compared to existing MCV2 products in China [26]. - The company is developing a DTcP vaccine for infants, which includes three pertussis antigens for better protection compared to existing products [29]. - The in-development DTcP booster vaccine is expected to complete all clinical trials by 2020 or earlier, being the first of its kind in China [30]. - The company is developing a Tdcp vaccine for adolescents and adults, which is expected to compete with world-class vaccines like Boostrix and Adacel [31]. - The company is developing an innovative tuberculosis booster vaccine, with the Phase I clinical trial showing good safety and tolerance [32]. - The company aims to launch Phase I clinical trials for the improved PCV13i vaccine by the end of 2019 and Phase III trials in 2020, with a new drug application expected in 2024 [33]. Financial Position and Assets - Total assets as of June 30, 2019, amounted to RMB 1,849,823 thousand, a significant increase from RMB 795,875 thousand in the previous year [87]. - Non-current assets totaled RMB 920,654 thousand, compared to RMB 574,871 thousand in the previous year, indicating a growth of approximately 60% [87]. - Current assets reached RMB 929,169 thousand, up from RMB 221,004 thousand, representing an increase of about 320% [87]. - The total equity attributable to owners was RMB 1,560,740 thousand, a rise from RMB 502,317 thousand, reflecting a growth of approximately 210% [87]. - The company raised RMB 1,127,770 thousand from issuing shares during the financing activities, a substantial increase from RMB 17,486 thousand in the previous year [92]. - The company maintained a net cash position as of June 30, 2019, making the debt-to-equity ratio not applicable [58]. - The company reported accounts payable of RMB 56,809,000 as of June 30, 2019, down from RMB 98,509,000 as of December 31, 2018 [141]. Corporate Governance and Compliance - The company is committed to high standards of corporate governance to protect shareholder interests and enhance corporate value [61]. - The independent auditor has reviewed the interim financial data in accordance with the relevant standards, affirming compliance with applicable accounting standards and regulations [20]. - The company has adopted the standard code for securities trading by its directors and supervisors, confirming compliance since the listing date [20]. - The audit committee has discussed the company's internal controls and financial reporting matters with management and the independent auditor [20]. - The company has confirmed that there are no undisclosed interests or short positions held by directors or senior management in the company's shares [70]. Employee and Shareholder Information - As of June 30, 2019, the company had 369 employees, with approximately 78% holding a bachelor's degree or higher [38]. - The total number of shares issued increased to 222,649,899 as of June 30, 2019, from 160,950,899 as of January 1, 2019, reflecting a growth of 38.34% [130]. - The company completed its employee stock ownership plan, with 2,931,941 shares being unlocked and vested as of March 28, 2019 [132]. - The total cumulative expense recognized for share-based payments was RMB 20,156,000 as of June 30, 2019, compared to RMB 33,089,000 as of December 31, 2018 [136].