Bio-Thera(SH:688177)2022-04-28 16:00Financial Performance - The company reported no profit distribution or capital reserve transfer to share capital for the year 2021[7]. - The company has not achieved profitability since its listing[5]. - The company reported a significant increase in revenue, reaching approximately $150 million for the fiscal year, representing a 25% year-over-year growth[24]. - The company reported a net profit margin of 10%, up from 8% in the previous year[24]. - The total assets of the company increased to $500 million, reflecting a 12% growth compared to the previous year[24]. - The company's operating revenue for 2021 reached ¥836,578,620.84, a significant increase of 352.23% compared to ¥184,989,902.44 in 2020[35]. - The net profit attributable to shareholders was ¥81,936,544.64 in 2021, recovering from a loss of ¥513,226,538.86 in 2020[35]. - The net cash flow from operating activities improved to ¥236,270,932.55, up from a negative cash flow of ¥358,036,787.87 in the previous year[35]. - Basic earnings per share (EPS) for 2021 was ¥0.20, a turnaround from a loss of ¥1.27 per share in 2020[36]. - The company's total assets increased by 9.39% to ¥2,617,782,079.77 at the end of 2021, compared to ¥2,393,159,821.09 at the end of 2020[35]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥35,923,321.89, compared to a loss of ¥562,291,518.69 in 2020[35]. - The weighted average return on equity (ROE) improved to 4.00% in 2021, up from -26.35% in 2020[39]. Research and Development - The company is investing in R&D, allocating $20 million towards the development of new monoclonal antibodies[24]. - Research and development (R&D) expenses accounted for 64.96% of operating revenue, a decrease of 239.19 percentage points from the previous year[39]. - Total R&D investment for the year was approximately ¥543.42 million, a decrease of 3.42% compared to the previous year, with R&D expenses accounting for 64.96% of operating revenue[123]. - The company has developed a comprehensive antibody drug development technology covering antibody discovery, screening, design, process development, and validation[149]. - The company has established a leading antibody drug technology platform and is advancing multiple projects using the IDEAL engine[105]. - The company is developing bispecific and multifunctional antibodies targeting tumors and autoimmune diseases, with early clinical studies for BAT7104 targeting CD47 and PD-L1 already underway[116]. - The company has developed immunogenicity prediction technology to identify potential flaws in candidate molecules early in the development process, optimizing antibody structure and function[112]. Product Development and Pipeline - The company has 2 products approved for market launch and 23 major products under research, with 2 products having submitted market applications and 2 in Phase III clinical trials[55][66]. - The product Pubeixi® (Bevacizumab Injection) received approval in November 2021 for treating advanced, metastatic, or recurrent non-small cell lung cancer and metastatic colorectal cancer[55]. - The company’s biosimilar drug, BAT1806 (Tocilizumab injection), is currently under review by NMPA for indications including rheumatoid arthritis and cytokine release syndrome[76]. - BAT2506 (Guselkumab) is in global Phase III clinical trials and targets TNF-α, providing a new treatment option for patients with autoimmune diseases[77]. - The company has established collaborations for the commercialization of its products in emerging markets, including partnerships with Cipla and Sandoz[73]. - The company’s R&D pipeline includes multiple innovative drugs targeting various diseases, with several in late-stage clinical trials[70]. - The company has submitted applications for 2 products and has 2 products in Phase III clinical trials, 2 in Phase II, and 9 in Phase I clinical trials[148]. Market and Competitive Landscape - The global biopharmaceutical market is expected to grow from $204.8 billion in 2015 to $768 billion by 2030, with a compound annual growth rate (CAGR) of 9.4%[95]. - The Chinese biopharmaceutical market is projected to grow from RMB 145.3 billion in 2015 to RMB 1,302.9 billion by 2030, with a CAGR of 13.9%[95]. - The biopharmaceutical industry is highly competitive, with potential for rapid technological advancements that could impact existing products[164]. - The company faces risks related to the commercialization of its pipeline products, with potential market competition impacting profitability[160]. - The company is expanding into overseas markets, including the EU and the US, which may be affected by various geopolitical and economic factors[176]. Governance and Compliance - The audit report issued by Ernst & Young Huaming is a standard unqualified opinion[6]. - The company has not engaged in non-operational fund occupation by controlling shareholders or related parties[9]. - The company has not violated decision-making procedures for external guarantees[11]. - The board of directors was fully present at the board meeting[6]. - The company has a risk statement regarding forward-looking statements in the report[8]. - The company has established governance structures to protect minority shareholders, but risks remain regarding potential undue influence from major shareholders[179]. Sales and Marketing - User data showed a 30% increase in active users, totaling 1.2 million by the end of the fiscal year[24]. - The company plans to enhance its digital marketing strategy, aiming for a 40% increase in online engagement[24]. - The marketing team has expanded the sales network across China, achieving steady revenue growth for the drug Gelerit® (Adalimumab Injection)[155]. - The company has established a sales team of over 240 people, covering all provinces, municipalities, and autonomous regions in China, excluding Hong Kong and Macau[87]. Risks and Challenges - The company acknowledges the high costs and complexities associated with drug development, which may affect the success of its projects[161]. - The company faces risks related to the loss of key technical personnel, which could delay the development of in-progress products[166]. - There is uncertainty regarding the commercialization of in-progress products, which may not achieve market acceptance or expected sales[168]. - Regulatory changes in the healthcare sector could impact the company's operations and financial performance, particularly regarding drug pricing and market access[175].