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东曜药业(01875) - 2022 - 年度业绩
TOT BIOPHARMTOT BIOPHARM(HK:01875)2023-03-23 14:49

Financial Performance - The company's revenue for the year ended December 31, 2022, reached RMB 442,178 thousand, a significant increase of 479% compared to RMB 76,325 thousand in 2021[6] - The net loss was reduced by 81% to RMB 50,046 thousand, and the net cash flow from operating activities turned positive at RMB 59,929 thousand[6] - In 2022, the group's operating revenue increased by 479% year-on-year to RMB 442,178 thousand, driven by a significant rise in self-developed product sales, continuous development of CDMO business, and increased milestone licensing income[16] - The group's net loss narrowed by 81% year-on-year to RMB 50,046 thousand, and net cash flow from operating activities turned positive for the first time, amounting to RMB 59,929 thousand[16] - The company reported a net loss of RMB 50,046 thousand for the year, compared to a net loss of RMB 261,216 thousand in the previous year[44] - The company's cash and cash equivalents increased to RMB 417,769 thousand in 2022, up from RMB 152,805 thousand in 2021[47] - The company's financing activities generated a net cash inflow of RMB 212,082 thousand in 2022[38] - The company's weighted average number of ordinary shares issued increased to 639,307 thousand in 2022 from 573,360 thousand in 2021, indicating a rise of approximately 11.5%[64] - The company's total equity as of December 31, 2022, was RMB 715,439 thousand, compared to RMB 335,091 thousand in 2021[47] Revenue Breakdown - Product sales revenue amounted to RMB 304,361 thousand, while CDMO/CMO business revenue was RMB 72,538 thousand, and licensing income was RMB 54,151 thousand[6] - The total revenue from sales in 2022 was RMB 304,361 thousand, driven by steady growth in sales of the core product, Bevacizumab Injection (朴欣汀®)[108] - The CDMO/CMO business generated revenue of RMB 72,538 thousand in 2022, representing a 35% year-over-year growth[41] - The group's revenue from royalties in 2022 was RMB 54,151 thousand, an increase of RMB 48,208 thousand from RMB 5,943 thousand in 2021[91] Market Expansion and Strategy - In 2023, the company aims to accelerate international expansion and enhance brand influence while continuing to implement its CDMO strategic objectives[11] - The company has successfully completed multiple market launch applications in various countries to meet overseas market demand[21] - The company is actively expanding its market presence in second and third-tier cities through strategic partnerships and marketing initiatives[163] - The company has established a new sales promotion agreement with a third party, indicating a strategy for market expansion[104] Production Capacity and Development - The company has established a production scale of 20,000L for monoclonal antibodies, with an annual capacity design exceeding 300,000 liters[10] - The ADC commercialization production capacity has been enhanced, with a fully integrated ADC formulation workshop and antibody liquid production workshop achieving zero defects in EU Qualified Person audits[10] - The company completed 45 CDMO projects in 2022, including 18 ADC projects, 23 antibody projects, and 2 chemical drug projects, with 25 projects successfully delivered[182] - The company has established a comprehensive ADC industrialization platform with end-to-end capabilities, enhancing its market competitiveness[155] - The company has completed multiple clinical production batches of ADC drugs, meeting GMP standards and commercial requirements[193] Research and Development - Research and development expenses for the year were RMB 151,168 thousand, compared to RMB 214,699 thousand in the previous year[44] - The company has initiated the construction of a global R&D center with a total investment of approximately RMB 180 million, with expenditures of RMB 49,778 thousand incurred by December 31, 2022[137] - The company is advancing the clinical development of ADC candidate drug TAE020 and collaborating with Hengrui Medicine Co., Ltd. on the co-development of innovative antibody drug TAC020[168] Financial Obligations and Assets - The total liabilities increased to RMB 546,592 thousand in 2022 from RMB 375,172 thousand in 2021, indicating a significant rise in financial obligations[29] - The total equity and liabilities reached RMB 1,262,031 thousand in 2022, up from RMB 710,263 thousand in 2021, reflecting the company's growth trajectory[29] - Total assets as of December 31, 2022, amounted to RMB 1,262,031 thousand, an increase from RMB 710,263 thousand in 2021[47] Compliance and Quality Management - The company achieved a significant milestone by passing the EU QP audit in October 2022, enhancing its international quality management capabilities[125] - The company's antibody and ADC commercial production base in Suzhou passed the EU QP audit with zero defects, confirming compliance with EU GMP standards[170] - The company has established a commercial production quality management system compliant with international standards, passing GMP compliance checks for its antibody and ADC production facilities[169] ESG and Governance - The company has enhanced its ESG governance standards through various initiatives, integrating ESG concepts into routine management[197] - The company has implemented a series of pandemic prevention and control policies to ensure stable production capacity during challenging times[197] Future Market Projections - The Chinese biopharmaceutical market is projected to grow from RMB 410 billion in 2021 to RMB 710.2 billion by 2025, with a compound annual growth rate (CAGR) of 14.7%[141] - The ADC drug market in China is expected to grow rapidly, with a compound annual growth rate (CAGR) of 116.0% from 2021 to 2025, reaching a market size of 7.8 billion RMB by 2025[153] - The global biopharmaceutical CDMO market is projected to reach 35.3 billion USD by 2025 and 67.9 billion USD by 2030, while China's biopharmaceutical CDMO market is expected to reach 37.3 billion RMB by 2025 and 85.3 billion RMB by 2030[159]