Hiteck(SZ:300683)2022-04-22 16:00Financial Performance - The company's operating revenue for 2021 was ¥614,683,452.35, representing a 17.28% increase compared to ¥524,123,427.37 in 2020[20]. - The net profit attributable to shareholders in 2021 was ¥27,654,228.04, a significant turnaround from a loss of ¥25,025,702.16 in 2020, marking a 210.50% increase[20]. - The net profit after deducting non-recurring gains and losses was ¥5,591,250.83 in 2021, compared to a loss of ¥42,196,910.19 in 2020, reflecting a 113.25% improvement[20]. - The company's total assets increased by 23.37% to ¥2,697,511,886.43 at the end of 2021, up from ¥2,186,566,003.25 at the end of 2020[20]. - The net assets attributable to shareholders rose by 36.04% to ¥2,324,400,644.26 at the end of 2021, compared to ¥1,708,652,006.75 at the end of 2020[20]. - The company reported a basic earnings per share of ¥0.260 in 2021, a significant increase from a loss of ¥0.240 per share in 2020, representing a 208.33% improvement[20]. - The weighted average return on equity was 1.52% in 2021, recovering from -1.44% in 2020[20]. - The company generated a net cash flow from operating activities of ¥12,088,247.37 in 2021, a 161.35% increase from a negative cash flow of ¥19,703,010.29 in 2020[20]. - Total revenue for 2021 reached ¥614,683,452.35, representing a year-on-year increase of 17.28% compared to ¥524,123,427.37 in 2020[63]. - Revenue from pharmaceutical technology services was ¥281,289,134.51, accounting for 45.76% of total revenue, with a year-on-year growth of 24.91%[63]. - The revenue from raw materials and intermediates surged by 3,174.77% to ¥102,258,145.15, significantly increasing its contribution to total revenue[63]. - Domestic sales accounted for 98.54% of total revenue at ¥605,726,002.55, with a year-on-year increase of 15.58%[63]. - Direct sales contributed ¥435,423,553.92, representing 70.84% of total revenue, with a growth of 23.72% compared to the previous year[63]. Market and Industry Outlook - The biopharmaceutical industry is projected to grow significantly, with the global market expected to reach $456.7 billion by 2024, reflecting a compound annual growth rate (CAGR) of approximately 9.8% from 2019[31]. - China's biopharmaceutical market is anticipated to grow to ¥712.5 billion by 2024, with a CAGR of about 18.0% from 2019[32]. - The global CRO market size increased from 44.3 billion USD in 2015 to 62.6 billion USD in 2019, and is expected to reach 96 billion USD by 2024, with a CAGR of approximately 8.9% from 2019 to 2024[35]. - The overall CRO industry in China is characterized by a fragmented market with low concentration, presenting significant growth opportunities due to increasing pharmaceutical R&D investments[36]. - The pharmaceutical market in China is projected to grow from RMB 1,633 billion in 2019 to RMB 2,228 billion by 2024, with a compound annual growth rate (CAGR) of approximately 6.42%[107]. Research and Development - The company has established six high-end formulation R&D platforms, significantly improving the success rate of drug project development[37]. - The company is actively developing multiple small molecule generic drugs and APIs, with ongoing projects progressing smoothly[51]. - The company has submitted a new drug application for the recombinant tumor necrosis factor project, awaiting approval from the National Medical Products Administration (NMPA)[51]. - The company has completed process validation for the recombinant human nerve growth factor eye drops project, transitioning from a lyophilized powder injection to an eye drop formulation[51]. - The company has submitted a generic drug application for parecoxib sodium injection, which is intended for short-term treatment of postoperative pain[51]. - The company has established a database of pharmaceutical experts to support its research and development efforts and ensure compliance with regulatory requirements[46]. - The company is focused on optimizing its talent structure and building research platforms to strengthen its independent R&D capabilities[51]. - The company has a strong talent pool with over 60% of its R&D team holding master's or doctoral degrees, and 90% of the core team members have extensive experience in project development[56]. - The company has invested 200 million RMB in new technology for drug development, aiming to improve production efficiency by 30%[145]. - The company plans to increase its R&D budget by 40% in 2022, focusing on innovative therapies[145]. Governance and Compliance - The company emphasizes the importance of accurate financial reporting and has declared the financial report to be true, accurate, and complete[4]. - The company has established a comprehensive governance structure to ensure compliance with relevant laws and regulations[124]. - The company has established a profit distribution policy, stating that cash dividends should not be less than 20% of the distributable profits for the year[125]. - The board of directors consists of 9 members, including 3 independent directors, in compliance with relevant regulations[126]. - The company has a complete and independent governance structure, ensuring independence in assets, personnel, finance, and operations from the controlling shareholder[129]. - The company has established a strict external guarantee system, with no guarantees provided for the controlling shareholder or its controlled enterprises[135]. - The company held three temporary shareholder meetings in 2021, with investor participation rates of 57.15%, 58.14%, and 50.42% respectively[136]. - The company has emphasized the importance of independent oversight in its governance practices, as evidenced by the appointment of new independent directors[140]. - The internal control self-assessment report indicates that there were no significant defects in internal controls during the reporting period[167]. - The internal control audit report confirmed that the company maintained effective internal controls related to financial reporting as of December 31, 2021[171]. Environmental Responsibility - HaiTe Biopharma reported a total chemical oxygen demand (COD) discharge of 0.713 tons per year, which is below the approved limit of 2.4 tons per year[174]. - The company has a wastewater treatment capacity of 500 tons per day, ensuring that all wastewater is treated to meet discharge standards[175]. - HaiTe Biopharma's ammonia nitrogen discharge is 0.039 tons per year, significantly lower than the approved limit of 0.45 tons per year[174]. - The company has established a comprehensive environmental management system and has a dedicated team for environmental protection[175]. - HaiTe Biopharma has implemented an emergency response plan for environmental incidents, which has been filed with the environmental protection department[177]. - The company has conducted regular drills to ensure effective response to potential environmental emergencies[177]. - HaiTe Biopharma has reported no administrative penalties related to environmental issues during the reporting period[179]. Strategic Initiatives - The company is focused on expanding its product pipeline in the fields of neurology and oncology, enhancing its market position[59]. - The company is constructing a new antiviral production facility, with the 103 antiviral workshop expected to be delivered within the year[115]. - The company is actively monitoring national pharmaceutical policies to mitigate risks associated with drug registration and market competition[116]. - The company aims to reduce reliance on single products through the acquisition of Hankan Pharmaceutical, enhancing its research and development capabilities[100]. - The company is in the process of acquiring a 6.9416% stake in Beijing Shadong Biological Technology Co., Ltd., indicating strategic expansion efforts[158]. - The company is also seeking to apply for a comprehensive credit facility from banks, which may enhance its financial flexibility[158]. Employee Engagement and Development - The total number of employees at the end of the reporting period was 1,143, with 268 in the parent company and 875 in major subsidiaries[160]. - The company employed 592 technical personnel, 336 production personnel, and 86 sales personnel, reflecting a strong focus on technical expertise[160]. - The educational background of employees included 11 with doctoral degrees, 186 with master's degrees, and 484 with bachelor's degrees, indicating a highly educated workforce[160]. - The company maintained a comprehensive salary system, ensuring timely payment of salaries, holiday bonuses, performance bonuses, and year-end bonuses despite the ongoing pandemic[161]. - In 2021, the company organized three training sessions focusing on various aspects of the pharmaceutical industry, enhancing employee knowledge and skills[162]. - The company conducted 8 Hiteck talk events to foster a culture of learning and sharing among employees, promoting engagement and collaboration[162]. Risks and Challenges - The company faces various risks including industry policy risks, new drug registration and market risks, and new drug development risks, which are detailed in the management discussion and analysis section[5]. - The report does not provide specific user data or performance guidance for the upcoming periods[5]. - There is no indication of market expansion or mergers and acquisitions in the current report[5]. - The CPT project is undergoing a Phase III clinical trial and is awaiting approval, with potential market risks if not included in the medical insurance directory[117]. - The high-end API production base project is significant, with potential risks related to market demand and policy changes affecting project viability[119].