Allist(688578)2023-04-26 16:00Financial Performance - The company reported a profit distribution plan for 2022, which includes no cash dividends, no stock bonuses, and no capital reserve transfers to increase share capital[4]. - The company has not achieved profitability since its listing[3]. - The audit report issued by PwC confirms the financial statements are true, accurate, and complete[4]. - The company's operating revenue for 2022 was CNY 791,002,454.27, representing a 49.22% increase compared to CNY 530,094,158.47 in 2021[20]. - The net profit attributable to shareholders for 2022 was CNY 130,520,677.23, a significant increase of 614.22% from CNY 18,274,567.01 in the previous year[20]. - The net cash flow from operating activities reached CNY 91,629,611.67, up 212.82% from CNY 29,291,075.24 in 2021[20]. - The company achieved sales revenue of CNY 790,323,498.88 from the product Fumetin, marking a 235.29% increase compared to the previous year[22]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021[21]. - The weighted average return on net assets was 4.24%, an increase of 3.62 percentage points compared to 0.62% in the previous year[21]. - The company reported a net profit of CNY 79,374,984.63 after deducting non-recurring gains and losses, marking a turnaround from a loss in the previous year[22]. - Total assets at the end of 2022 were CNY 3,442,172,227.84, a 9.96% increase from CNY 3,130,259,503.93 at the end of 2021[20]. - The company's net assets attributable to shareholders increased to CNY 3,187,055,657.81, reflecting a 7.19% growth from CNY 2,973,264,920.91 in 2021[20]. Research and Development - The company plans to invest RMB 200 million in research and development for innovative drugs over the next two years[10]. - Research and development expenses totaled CNY 191,750,085.89, a decrease of 13.86% year-over-year, with R&D expenses accounting for 24.24% of operating revenue[23]. - The company has multiple new drug candidates in preclinical research, with plans to submit IND applications for these projects in the future[41]. - The company is currently in the preclinical stage for the KRAS G12D inhibitor, with a cumulative investment of ¥5,719.64 million[79]. - The company has established a complete new drug research and development system, focusing on innovative drug development as its core strategy[72]. - The company has a strong pipeline with multiple products in various stages of development, indicating a commitment to expanding its oncology portfolio[122]. Product Development and Market Strategy - The company is advancing its core product, Vomeletinib, which is a third-generation EGFR-TKI, aimed at treating advanced non-small cell lung cancer (NSCLC) with EGFR mutations[10]. - Future guidance includes an expected revenue growth of 30% for 2023, driven by the anticipated launch of new products and market expansion strategies[10]. - The company is focusing on expanding its market presence in North America and Europe, targeting a 15% market share in these regions by 2025[10]. - The company is exploring potential mergers and acquisitions to bolster its product pipeline and expand its therapeutic offerings[10]. - The company aims to complete ongoing research and submit for conditional approval for drugs that address severe life-threatening diseases with no effective treatments available[14]. - The company is focused on obtaining priority review for innovative drugs that are urgently needed for major infectious diseases and rare diseases[14]. - The company is conducting a randomized, double-blind, placebo-controlled Phase III trial to compare the efficacy and safety of the drug in patients with EGFR mutation-positive NSCLC[13]. Corporate Governance - The company has not disclosed any special arrangements for corporate governance[5]. - The company has established a governance structure that complies with relevant laws and regulations, ensuring effective operation and management[141]. - The company held its first extraordinary general meeting of 2022 on March 28, 2022, where four proposals, including the election of non-independent directors, were approved[143]. - The annual report for 2022 indicates that the company has maintained its governance structure without any significant changes in the reporting period[144]. - The company has a total of 10 directors, with 5 being independent directors, ensuring a balanced governance structure[146]. - The company has not engaged in any significant related-party transactions that could affect its independence[145]. - The company has established specialized committees under the board, including audit, nomination, compensation, and strategic committees[167]. Environmental and Social Responsibility - The company invested 1.75 million yuan in environmental protection during the reporting period, demonstrating its commitment to sustainable practices[192]. - The company is not listed as a key pollutant discharge unit by the Shanghai Environmental Protection Department, indicating compliance with environmental regulations[193]. - The company has not faced any administrative penalties related to environmental issues during the reporting period, reflecting its adherence to environmental laws[194]. - The company has implemented carbon reduction measures, resulting in a decrease of approximately 60 tons of CO2 equivalent emissions annually[200]. - The company has established a new 64KW solar water heating system for the cafeteria and showers, expected to save 60,000 KW.H of electricity per year[200]. - The company promotes green office practices and resource conservation to enhance efficiency in electricity and water usage[197]. Market and Competitive Landscape - The domestic anti-tumor drug market reached RMB 28.1 billion in 2019, growing 46.35% from RMB 19.2 billion in 2016, with projections to exceed RMB 101.8 billion by 2030[60]. - The non-small cell lung cancer market in China grew from RMB 17.2 billion in 2016 to RMB 44.9 billion in 2020, with expectations to reach RMB 118.6 billion by 2025[62]. - The global anti-tumor drug expenditure was approximately USD 143.4 billion in 2019, with a year-on-year growth of 11.9%[59]. - The company faces risks related to reliance on a single product, Vorinostat, which may limit its operational sustainability[88]. - The competitive landscape for Vorinostat includes several approved and in-development third-generation EGFR-TKIs, increasing market competition risks[88]. Employee and Talent Management - The company emphasizes talent acquisition and training to strengthen its workforce in R&D and sales[36]. - The total number of employees in the parent company is 393, while the total number of employees in major subsidiaries is 477, resulting in a combined total of 870 employees[173][174]. - The company has implemented a competitive compensation policy that considers internal equity and industry standards, providing various benefits and incentives to attract and retain talent[176]. - A digital learning platform named "Aixuetang" was launched in 2021 to enhance employee training and development, offering various courses and resources[179]. Risk Management - The company has detailed various risk factors it may face during operations in the report[4]. - The report includes a forward-looking statement risk declaration, indicating that future plans and strategies do not constitute a substantive commitment to investors[5]. - The company is exposed to potential regulatory changes in the pharmaceutical industry, which could adversely affect its operations[90]. - If Vorinostat is removed from the medical insurance catalog, it may significantly impact its market share and sales revenue[91].