Bio-Thera(SH:688177)2024-03-28 16:00Financial Performance - The company reported a net loss attributable to shareholders of 85,867,423.14 CNY for the reporting period, a decrease compared to the previous year[18]. - Basic earnings per share for 2023 was -0.95 CNY, an improvement from -1.16 CNY in 2022[16]. - The weighted average return on net assets was -27.98%, a decrease of 1.97 percentage points from the previous year[16]. - The company’s net profit after deducting non-recurring gains and losses was -50,814,675.39 CNY, reflecting a significant loss reduction[18]. - The diluted earnings per share also stood at -0.95 CNY, consistent with the basic earnings per share[16]. - The company experienced a decrease in the weighted average return on net assets after deducting non-recurring gains and losses, which was -33.46%[17]. - The company’s operating revenue for 2023 was ¥704,794,652.84, representing a 54.86% increase compared to ¥455,131,950.13 in 2022[196]. - The net profit attributable to shareholders for 2023 was -¥394,531,428.45, an improvement from -¥480,398,851.59 in 2022[196]. - The adjusted net profit excluding non-recurring gains and losses for 2023 was -¥471,830,530.42, an improvement from -¥522,645,205.81 in 2022[196]. - The net cash flow from operating activities decreased by ¥48,053,035.12 compared to the previous year, primarily due to a smaller increase in cash received from sales compared to cash paid for operating activities[198]. - The total assets at the end of 2023 were ¥2,287,097,856.78, a 4.93% increase from ¥2,179,736,935.85 at the end of 2022[196]. - The net assets attributable to shareholders decreased by 24.55% to ¥1,212,715,420.61 at the end of 2023 from ¥1,607,255,215.08 at the end of 2022[196]. - In Q1 2023, the operating revenue was ¥154,927,728.15, while in Q2 2023, it was ¥159,738,745.66[199]. - The net profit attributable to shareholders in Q4 2023 was -¥12,351,191.33, showing a significant reduction in losses compared to earlier quarters[199]. - The net profit attributable to shareholders in Q3 2023 was -¥128,559,363.86, indicating ongoing challenges[199]. Research and Development - Research and development expenses accounted for 109.06% of operating revenue, a decrease of 26.37 percentage points compared to 2022[17]. - The total R&D investment for the year was approximately ¥768.64 million, representing a 24.70% increase compared to the previous year[175]. - The ratio of total R&D investment to operating income decreased by 26.37 percentage points to 109.06%[175]. - The company has submitted 94 patent applications and received 5 patents, with a total of 57 authorized patents and 213 pending applications as of December 31, 2023[85]. - The company has multiple products in clinical research and preclinical stages, indicating a robust pipeline for future growth[90]. - The company is developing multiple bispecific antibodies and multifunctional molecules targeting tumors and autoimmune diseases, with clinical studies for BAT7104 already underway in Australia and domestically[171]. - The company has developed several ADCC-enhanced antibody candidates that are currently in various clinical trial stages[157]. - The company has established a leading antibody drug technology platform, IDEAL, which is actively advancing multiple projects in clinical research[151]. - The company has a total of 213 pending patent applications, covering various regions including mainland China, Hong Kong, Macau, Taiwan, and international jurisdictions[172]. Product Development and Approvals - The company received FDA approval for two products during the reporting period: BAT1806 (Tocilizumab) in September 2023 and BAT1706 (Bevacizumab) in December 2023, marking significant milestones[41]. - BAT1806 is the first biosimilar Tocilizumab approved by the FDA and the first monoclonal antibody developed and produced by a Chinese company to receive FDA approval[41]. - BAT1806 (Tocilizumab) received approval from the National Medical Products Administration in January 2023 and from the FDA in September 2023, marking it as the first biosimilar of Tocilizumab approved in both China and the US[67]. - BAT1706 (Bevacizumab) has been commercialized in multiple global regions, including partnerships with BeiGene in China and Sandoz AG in the US and Europe[66]. - The company has established commercial production capabilities for Gelerit®, Pubeixi®, and Shilili® and has a robust GMP management system[44]. - The company has signed commercialization agreements for BAT2206 (Ustekinumab) and BAT1706 (Bevacizumab) in Brazil, Indonesia, Pakistan, and Afghanistan, expanding its global market presence[56]. - The company has established a comprehensive quality management system compliant with international standards, ensuring product quality throughout the lifecycle[106]. - The company has successfully launched three biosimilar products, including BAT1706 (Bevacizumab), which received FDA approval and is marketed as Avzivi® in the U.S.[149]. - BAT2506 (Golimumab) has completed global Phase III clinical trials and targets TNF-α for treating autoimmune diseases, with market potential due to existing treatment limitations[70]. - The company has established multiple licensing and commercialization agreements for BAT1706 (Bevacizumab) in various international markets, including the U.S., Europe, and emerging countries[135]. - The company has signed licensing agreements for BAT1806 with Biogen for exclusive rights outside of China, enhancing international market development[109]. Market Trends and Opportunities - The global pharmaceutical market grew from $1.3 trillion in 2018 to $1.5 trillion in 2022, with projections to reach $2.1 trillion by 2030[112]. - The Chinese biopharmaceutical market increased from ¥262.2 billion in 2018 to ¥421 billion in 2022, with a compound annual growth rate (CAGR) of 12.6%[116]. - The global autoimmune disease treatment market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030[118]. - The global biopharmaceutical market is projected to grow from $263.1 billion in 2022 to $783.2 billion by 2030, with a compound annual growth rate (CAGR) of 12.4% from 2022 to 2026[141]. - The Chinese biopharmaceutical market is expected to grow from 1.6 trillion RMB in 2022 to 2.6 trillion RMB by 2030, with a CAGR of 7.8% from 2022 to 2026[141]. - The aging population in China, with over 29.7 million people aged 60 and above, is expected to drive the demand for biopharmaceuticals, providing stable market support[139]. - The global tumor immunotherapy market reached $50.2 billion in 2022 and is expected to grow to $203.5 billion by 2030, indicating a significant growth trajectory[145]. - The ADC drug market grew from $2 billion in 2018 to $7.9 billion in 2022, with a compound annual growth rate (CAGR) of 40.4%, projected to reach $64.7 billion by 2030[145]. - The Chinese ADC drug market was valued at 800 million RMB in 2022 and is expected to reach 66.2 billion RMB by 2030[145]. - The biopharmaceutical market's share of biologics in autoimmune disease treatment is projected to exceed 80% by 2030[118]. Corporate Governance and Compliance - The company’s financial report was prepared in accordance with international accounting standards and Chinese accounting standards[19]. - The company has ensured the accuracy and completeness of the annual report, with all board members present at the meeting[22]. - The company emphasizes a data integrity and traceability quality management approach to maintain high standards in drug production[106]. - The commercial department has optimized market promotion strategies, increasing reliance on external CSOs for market outreach[107]. - The company is committed to independent innovation while actively seeking external collaboration opportunities globally[84]. - The company plans to not distribute profits or increase share capital from capital reserves for the 2023 fiscal year, pending shareholder approval[185]. - The company has not yet achieved profitability since its listing[179]. - The company has not capitalized any R&D expenditures during the reporting period[175].