Allist(SH:688578)2023-06-21 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 reported a significant increase in revenue for 2022, reaching RMB 1.5 billion, representing a year-over-year growth of 25% [10]. - 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]. - Basic earnings per share for 2022 were CNY 0.29, a 625.00% increase from CNY 0.04 in 2021 [21]. - The total assets of the company at the end of 2022 were CNY 3,442,172,227.84, reflecting a 9.96% increase from CNY 3,130,259,503.93 in 2021 [20]. - The weighted average return on net assets for 2022 was 4.24%, an increase of 3.62 percentage points from 0.62% in 2021 [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]. Research and Development - The company is actively developing new products, including the third-generation EGFR-TKI, with a focus on late-stage non-small cell lung cancer treatment [10]. - Research and development efforts are focused on innovative drugs, with a pipeline that includes several first-in-class and best-in-class candidates [11]. - The company has established partnerships with Contract Research Organizations (CROs) to enhance its drug development capabilities [10]. - The company is focused on obtaining conditional approval for drugs that treat severe life-threatening diseases with no effective treatment options [14]. - The company aims to apply for priority review for drugs that are clinically urgent, such as innovative drugs for major infectious diseases and rare diseases [14]. - The company is dedicated to enhancing its research and development capabilities to improve drug efficacy and safety [12]. - The R&D investment for 2022 was CNY 191,750,085.89, a decrease of 13.86% from the previous year, with R&D expenses accounting for 24.24% of operating revenue [23]. - The company is focused on real-world studies to gather evidence applicable to clinical practice [13]. - The company has a comprehensive drug development system covering all stages from drug discovery to commercialization [42]. - The company has received NDA approval for AST-NI1901, which targets adult patients with specific EGFR mutations in non-small cell lung cancer (NSCLC) [126]. - The company has a diverse pipeline with multiple products in various stages of development, including both approved and investigational drugs targeting NSCLC [125][126]. Market Strategy and Expansion - Future guidance suggests an expected revenue growth of 30% for 2023, driven by new product launches and market expansion strategies [10]. - The company plans to expand its market presence in North America and Europe, targeting a 15% market share in these regions by 2025 [10]. - The company has established a marketing team of nearly 650 members to enhance the promotion of Furmonertinib [33]. - An exclusive promotion agreement was signed with Jiangsu Fosun Pharmaceutical Sales Co., Ltd., covering over 2,000 hospitals to expand market reach [34]. - The company is actively recruiting talent with international pharmaceutical experience to strengthen its workforce [36]. - The company aims to enrich its R&D product pipeline by continuously investing in product development and exploring new targets and compounds [141]. - The company will enhance its marketing capabilities by recruiting a strong marketing team and focusing on professional academic promotion to boost drug sales [140]. Clinical Trials and Product Development - The ongoing clinical trials for its lead product are expected to complete by Q4 2023, with potential market approval in early 2024 [10]. - The company plans to apply for first-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations [12]. - The second-line treatment indication targets adult patients with locally advanced or metastatic NSCLC who have progressed after EGFR-TKI treatment and have confirmed EGFR T790M mutations [13]. - 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 after radical resection [13]. - Furmonertinib demonstrated a median progression-free survival (PFS) of 20.8 months in first-line treatment for advanced NSCLC, significantly extending PFS compared to Gefitinib (11.1 months) with a risk reduction of 56% [44]. - The overall response rate (ORR) for Furmonertinib in second-line treatment for advanced NSCLC was reported at 74%, with a disease control rate (DCR) of 94% [45]. - Furmonertinib showed a CNS ORR of 84.6% and a CNS PFS of 19.3 months in patients with CNS metastases, indicating strong efficacy in this challenging patient population [46]. Governance and Compliance - The company has not disclosed any special arrangements for corporate governance [5]. - The company emphasizes that forward-looking statements do not constitute substantive commitments to investors, highlighting investment risks [5]. - The board of directors has confirmed that all members attended the board meeting [4]. - The company has not reported any instances where more than half of the directors could not guarantee the authenticity, accuracy, and completeness of the annual report [5]. - The company has not faced any penalties from securities regulatory authorities in the past three years [162]. - The company has a commitment to ensuring the confidentiality of sensitive remuneration information for its key personnel [150]. - The company has established a compensation and assessment committee as of November 28, 2019, to review and formulate the remuneration policies for directors and management [160]. Environmental and Social Responsibility - The company invested 1.75 million RMB in environmental protection during the reporting period [194]. - The company is committed to ESG practices, enhancing internal governance and ensuring compliance with environmental laws [194]. - The company promotes green office practices and energy-saving actions, aiming to reduce electricity and water resource consumption through centralized office management and electronic processes [199]. - Major pollutants include waste gas, wastewater, noise, general solid waste, and hazardous solid waste, with specific management measures in place such as dust collection equipment and professional wastewater treatment facilities [200].