Bio-Thera(SH:688177)2021-03-04 16:00Financial Performance - As of December 31, 2020, the company's revenue was CNY 184.99 million, with a net loss attributable to shareholders of CNY 513.23 million[5]. - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year, representing a 25% year-over-year growth[26]. - Bio-Thera reported a significant increase in revenue, reaching approximately CNY 500 million in 2020, representing a year-over-year growth of 25%[34]. - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to $600 million[28]. - Gelerit's sales revenue for 2020 was ¥184,989,900, benefiting from its competitive pricing compared to the original drug[128]. - The company's operating revenue for 2020 was RMB 184,989,902.44, an increase of RMB 184,289,902.44 compared to the previous year, primarily due to the launch of the product Gelerit[43]. - The net profit attributable to the parent company was -¥513,226,538.86, a decrease in loss of ¥509,395,287.60 compared to the previous year[143]. - The company's cash flow from operating activities was -¥358,036,787.87, showing an improvement from -¥597,975,664.90 in the previous year[144]. Research and Development - The company incurred R&D expenses of CNY 562.65 million, indicating a need for continued significant investment in R&D for ongoing projects and new drug commercialization[5]. - The company has one product approved for sale and 20 products in the pipeline, with 3 in Phase III clinical trials and 2 in Phase II clinical trials[6]. - The company has allocated CNY 100 million for research and development in 2021, aiming to advance its innovative therapies[34]. - Research and development expenses accounted for 304.15% of operating revenue in 2020, a substantial increase from 90,930.15% in 2019[42]. - The company has submitted a total of 62 patent applications during the reporting period, with 8 patents granted, bringing the total granted patents to 39[97]. - The company has a robust R&D team of 268 members, possessing diverse scientific knowledge and experience in drug discovery and clinical development[92]. - The company is focused on developing innovative drugs for major diseases, including cancer and autoimmune disorders, with a strong emphasis on patient welfare[56]. Market Strategy and Expansion - The company is focused on building a comprehensive marketing team to support market expansion and academic promotion efforts[11]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of the next fiscal year[26]. - Bio-Thera plans to enhance its market presence in Europe and North America, targeting a 15% market share in these regions by 2025[35]. - The company is exploring strategic partnerships for potential mergers and acquisitions to bolster its market position[36]. - The company is committed to enhancing its digital marketing strategies to reach a broader audience, aiming for a 25% increase in online engagement[36]. - The company is leveraging national drug procurement policies to enhance the prescription preference for its products among public hospital doctors[96]. Product Development and Pipeline - The product "Geleli" (Adalimumab Injection) was approved and began sales in January 2020, contributing to the company's revenue[10]. - The company has submitted applications for two additional products, BAT1706 and BAT2094, which are currently under review[6]. - BAT1706 (bevacizumab) is currently in the application stage for market approval in China, the US, and the EU, with global sales of the original drug reaching approximately USD 7.1 billion since its launch in 2009[57]. - The company is focusing on expanding its product pipeline, with 5 new monoclonal antibodies expected to enter clinical trials in the next 12 months[36]. - BAT8001 has entered Phase III clinical trials in China, targeting HER2-positive metastatic breast cancer and solid tumors, with a total investment of approximately ¥24.65 billion[5]. - BAT2206 is currently in Phase I clinical trials, designed to block IL-12 and IL-23, with an investment of around ¥24.09 billion, targeting plaque psoriasis[6]. - BAT1306, a monoclonal antibody targeting PD-1, is in Phase II clinical trials with an investment of approximately ¥5.95 billion, aimed at EBV-associated gastric cancer[7]. Financial Position and Assets - The company's total assets at the end of 2020 were RMB 2,393,159,821.09, a significant increase of 135.93% from the end of 2019[42]. - The net assets attributable to shareholders increased to RMB 2,005,603,082.84 at the end of 2020, a 218.01% increase from the end of 2019, primarily due to a public offering of 60 million shares[43]. - The company's cash and cash equivalents at the end of the reporting period amounted to ¥283,509,080.91, representing 11.85% of total assets, a significant increase of 625.57% compared to the previous year[122]. - Trading financial assets reached ¥955,769,021.30, accounting for 39.94% of total assets, with the increase attributed to funds from the initial public offering used for purchasing structured deposits[122]. - Accounts receivable increased to ¥55,410,607.11, representing 2.32% of total assets, primarily due to the sales of the product Gelerit[122]. Risks and Challenges - The company faces significant risks related to drug development, including high failure rates and the uncertainty of regulatory approvals[7]. - The company anticipates ongoing large-scale R&D investments, with the potential for cumulative losses to continue to grow, risking compliance with listing rules[12]. - The company acknowledges the competitive nature of the pharmaceutical market, which may impact the commercialization of its products[10].