Financial Performance - The company achieved a revenue of RMB 780,629 thousand, representing a year-on-year growth of 77%[13] - Product sales revenue reached RMB 630,207 thousand, a significant increase of 107% year-on-year, primarily driven by the strong sales performance of the core product, Puxintin (Bevacizumab injection)[13] - CDMO/CMO business revenue was RMB 140,898 thousand, reflecting a year-on-year growth of 94%[13] - The adjusted EBITDA was RMB 40,041 thousand, showing a substantial increase of 274% year-on-year[18] - The net loss narrowed to RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% compared to the previous year[18] - The adjusted net loss for the year was RMB 37.76 million, a 25% improvement compared to the previous year, while total comprehensive loss decreased by 18% to RMB 36.02 million[28] - The adjusted net loss for 2023 was RMB 8,162 thousand, a decrease of RMB 25,773 thousand compared to the adjusted net loss of RMB 33,935 thousand in 2022[35] - Total revenue for 2023 reached RMB 780,629 thousand, representing a 77% increase from RMB 442,178 thousand in 2022[36] - Product sales revenue for 2023 was RMB 630,207 thousand, up from RMB 304,361 thousand in 2022, primarily due to a significant increase in sales of the core product, Puxintin®[37] - CDMO/CMO business revenue for 2023 was RMB 140,898 thousand, an increase of RMB 68,360 thousand from RMB 72,538 thousand in 2022, attributed to large-scale expansion of the CDMO/CMO business segment[37] Operational Highlights - The company maintained a positive operating cash flow of RMB 56,431 thousand[18] - The company has established a high-standard commercial production platform integrating antibodies, ADC raw solutions, and formulations[22] - The CDMO business experienced a growth rate exceeding the industry average, with 39 new projects added in 2023, representing a 44% year-over-year increase, totaling 95 projects[23] - Among the new projects, 30 are related to ADC, highlighting the company's differentiated advantage in this field, with ADC projects now accounting for 65% of both revenue and project count among the 65 ongoing projects[23] - The company has accumulated 6 pre-BLA projects, with 4 being newly added, showcasing its strong capabilities in commercializing CDMO projects[23] - The company optimized its production lines, significantly enhancing flexibility and capacity, with annual production capacities of 300,000 liters for antibody raw materials and 20 million doses for formulations[25] - The second ADC formulation production line commenced operations in June 2023, with over 10 projects already produced, including 3 pre-BLA projects[25] - The total number of employees reached 551 as of December 31, 2023, with the CDMO team increasing by 34% compared to the end of 2022, now comprising 84% of the total workforce[24][26] Strategic Initiatives - Strategic collaborations have been formed with multiple companies, including Lepu Biopharma and Shijian Biopharma, to enhance ADC CDMO differentiation advantages[22] - The company initiated the construction of a global R&D service center in 2021, which officially opened on October 19, 2023, covering an area of 25,000 square meters[25] - The company expects to complete its first overseas approval in 2024, which will provide new treatment options for a broader patient population globally[26] - A strategic partnership was formed with Sugar Ridge Bio to develop the DisacLink™ ADC technology platform, enhancing the company's competitive edge in ADC drug development[70] - The company is focused on becoming a leading CDMO partner in the bioconjugate drug sector, enhancing service quality and technical capabilities to build customer loyalty[99] Research and Development - Research and development expenses for 2023 were RMB 103,890 thousand, down from RMB 151,168 thousand in 2022, mainly due to streamlining of product pipelines[38] - The company streamlined its R&D pipeline, leading to a continuous decrease in new drug R&D expenses while actively promoting sales of already launched products to improve cash flow[83] - The commercialization agreement for TAB014, aimed at treating wet age-related macular degeneration (wAMD), was signed with a subsidiary of Zhaoke Ophthalmology, with Phase III clinical trial patient enrollment completed ahead of schedule on September 16, 2023[83] Corporate Governance - The company has adopted the principles and provisions of the corporate governance code as outlined in Appendix C1 of the listing rules[142] - The board is committed to maintaining high ethical standards and ensuring activities are conducted with accountability, transparency, fairness, and responsibility[142] - The company has established its own corporate governance policy, which includes principles and practices from the corporate governance code[142] - The board of directors consists of seven members, including one executive director and three independent non-executive directors, ensuring a balanced skill set and independence[146] - The company has implemented strict written guidelines for employees regarding insider trading, ensuring adherence to ethical standards[144] Management and Leadership - Yin Li joined the company as Chief Technology Officer in November 2023, bringing over 30 years of experience in the chemical and biopharmaceutical industry[127] - Dr. Pan Zhiwei was appointed as Vice President of CMC in March 2023, responsible for process development and project management, with previous experience at Shanghai Junshi Biosciences[128] - Li Hongyang will join the company as Vice President of Quality in January 2024, with extensive experience in quality management from Novartis and other multinational pharmaceutical companies[129] - The management team has a strong background in biopharmaceuticals, with members having held significant positions in leading companies like Amgen and Bayer[127][128] Market Expansion - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2025[124] - The company initiated registration applications for market approval in 23 overseas countries, with 13 applications already accepted, aiming for the first overseas approval in 2024[87] Financial Position - The company's cash and cash equivalents decreased to RMB 351,600 thousand in 2023 from RMB 417,769 thousand in 2022, a reduction of RMB 66,169 thousand[60] - Operating cash inflow for 2023 was RMB 56,431 thousand, down from RMB 59,929 thousand in 2022, reflecting a decrease of approximately 5.8%[60] - The company's total liabilities rose to RMB 739,415 thousand in 2023 from RMB 546,592 thousand in 2022, marking an increase of about 35.1%[58] - The current ratio decreased to 1.8 in 2023 from 2.5 in 2022, indicating a decline in liquidity[62] Awards and Recognition - In 2023, the company achieved significant growth in the CDMO business, receiving multiple industry awards and recognition, including being ranked in the top 10 most growth-oriented CDMO companies in China[114]
东曜药业(01875) - 2023 - 年度财报