maccura(SZ:300463)2022-04-19 16:00Financial Performance - Maccura Biotechnology reported a revenue of 1.2 billion CNY for the fiscal year 2021, representing a year-over-year increase of 15% compared to 2020[39]. - The company achieved a net profit of 300 million CNY in 2021, which is a 20% increase from the previous year[39]. - The company's operating revenue for 2021 was ¥3,980,647,183.47, representing a 7.47% increase from ¥3,703,877,006.69 in 2020[46]. - The net profit attributable to shareholders for 2021 was ¥956,604,404.94, a 20.49% increase compared to ¥793,917,986.86 in 2020[46]. - The net cash flow from operating activities reached ¥1,616,683,215.88, marking a significant increase of 47.77% from ¥1,094,048,810.10 in 2020[46]. - The basic earnings per share for 2021 was ¥1.7308, up 20.77% from ¥1.4331 in 2020[46]. - The company reported a gross margin of 60% for 2021, consistent with the previous year, indicating stable cost management[39]. - The company achieved a revenue of 3.981 billion in 2021, a year-on-year increase of 7.47%, and a net profit of 957 million, up 20.49%[84]. - Sales revenue from self-developed products reached 2.3 billion, growing by 24.08%, while agency product sales declined by 9.76% to 1.635 billion[84]. - The gross profit margin for comprehensive sales increased from 53% to 58% year-on-year[84]. Market Expansion and Strategy - Maccura plans to expand its market presence in Southeast Asia, targeting a 30% increase in market share by 2023[39]. - The company is exploring potential acquisitions to enhance its product portfolio and expand its technological capabilities[39]. - The company aims to enhance its market competitiveness by promoting laboratory automation and self-sufficiency, thereby increasing its domestic market share[78]. - The company is focusing on enhancing its market presence and distribution capabilities, particularly in overseas markets, with 143 new overseas channels added during the reporting period[86]. - The company is actively pursuing strategic partnerships to facilitate market expansion and product development in emerging markets[179]. - The company is expanding its market reach with new registrations in various international markets, including significant numbers in Turkey, Egypt, and the Philippines[157]. Research and Development - The company has increased its R&D investment to strengthen its core technologies and reduce the risk of technology leakage[11]. - The company invested 25% to 30% of its net profit annually into R&D, totaling approximately 1 billion over the past five years, which is 13.4% of self-developed product revenue[92]. - The company has established three major R&D platforms covering biological raw materials, reagents, and instruments, with 906 R&D personnel accounting for 31.23% of total employees[92]. - The company has initiated a total of 346 research and development projects, expecting to deliver over 20 technological innovations and new products annually, with 433 patents held, including 203 invention patents[95]. - The company is focusing on developing advanced testing technologies, including direct chemiluminescence methods for various assays[172]. - The company is enhancing its research and development capabilities to support the launch of new diagnostic products[163]. Product Development and Innovation - The company has developed a comprehensive product line in in vitro diagnostic solutions, covering over 1,500 diagnostic reagents and more than 30 diagnostic instruments across nine major product platforms[77]. - The company has successfully launched innovative products, including the world's first creatinine reagent resistant to hydroxyphenylsulfonic acid interference and a new COVID-19 nucleic acid test kit approved for emergency use in Sichuan Province[79]. - The company has developed rapid and precise COVID-19 nucleic acid detection products, receiving registrations in multiple countries, which will strengthen its molecular detection product brand[132]. - The company is focusing on upgrading existing products based on customer and market demands, particularly in inflammation and diabetes testing[135]. - The company is expanding its product offerings in the field of autoimmune disease testing, with several new tests in the registration phase[138]. - The company has introduced a new series of COVID-19 related testing kits, including neutralizing antibody testing kits, which are also self-declared[172]. Regulatory Compliance and Quality Control - The company is committed to maintaining compliance with regulatory standards in the EU and EEA regions for its new products[164]. - The company has established a quality management system certified by TUV ISO9001 and ISO13485[97]. - The company is enhancing its quality control products, which are essential for maintaining the accuracy of diagnostic tests[168]. - The company actively participates in the formulation of industry standards, having completed the assignment of values for 33 standard substances or national standards during the reporting period[99]. Supply Chain and Operational Efficiency - The company is enhancing its supply chain efficiency and investing in cold chain logistics to improve product delivery[39]. - The company has a strong emphasis on procurement, ensuring quality by purchasing raw materials in bulk for six months to a year[80]. - The company operates under a sales-driven production model, aligning production plans with customer orders and demand forecasts[82]. - The company is transitioning its sales model from a mix of direct and distributor sales to primarily distributor-based sales, especially in the domestic market[83]. Challenges and Risks - The company acknowledges the risk of raw material supply shortages due to reliance on imports and is working to increase self-sufficiency in raw material production[15]. - The company is adapting its operational strategies in response to new regulations in the medical device industry, which may impact its business operations[7]. - The company is closely monitoring changes in industry regulations and adjusting its business strategies accordingly to mitigate potential risks[10].