Financial Performance - Revenue increased by 36.7% from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, driven by a 27.4% growth in mainland China[6] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[6] - Net loss decreased by 45.1% from RMB 5,811.83 million in 2023 to RMB 3,192.50 million in 2024[7] - Adjusted net loss decreased by 42.9% from RMB 5,339.04 million in 2023 to RMB 3,045.72 million in 2024, reflecting effective cost reduction strategies[8] - The company achieved a net loss of RMB 319,250,000 in 2024, which is a 45.0% improvement compared to a net loss of RMB 581,183,000 in 2023[46] - The pre-tax loss for 2024 was RMB 144,408,000, significantly reduced from RMB 282,437,000 in 2023[63] - The adjusted loss for the year improved from RMB 533.9 million in 2023 to RMB 304.6 million in 2024, reflecting a reduction of about 43.1%[99] Research and Development - R&D costs reduced by 36.2% from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[6] - The company has made steady progress with its preclinical candidates, including ATG-042, ATG-201, ATG-102, ATG-106, ATG-107, and ATG-110[14] - The new "2+1" T cell engager platform, AnTenGagerTM, has shown steady progress, enhancing efficacy and reducing the risk of cytokine release syndrome (CRS)[15] - The Phase I trials for ATG-101 in treating advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[17] - The company is conducting key clinical trials in the US for its bispecific antibody products[22] - The company has initiated multiple Phase II and III clinical trials for its drug candidates[22] - The company reported an overall response rate (ORR) of 42.9% in a trial for ATN-022 in advanced or metastatic gastric cancer patients[41] Product Development and Approvals - Selinexor received approval for reimbursement in South Korea for treating relapsed or refractory multiple myeloma starting July 1, 2024[9] - New indications for Selinexor were approved in China for treating relapsed/refractory diffuse large B-cell lymphoma in July 2024[9] - The company has received NDA approvals for its product, Cevinostat, in multiple regions including mainland China, Australia, and several Southeast Asian countries[20] - The first commercial product, XPOVIO® (Selinexor), is a selective nuclear export inhibitor approved for multiple myeloma and solid tumors, with exclusive rights in Greater China and several other regions[24] - XPOVIO® received accelerated approval from the FDA for treating adult patients with relapsed/refractory multiple myeloma after at least four lines of therapy[25] - The company has received conditional approval from NMPA for XPOVIO® to treat adult patients with relapsed/refractory DLBCL after at least two lines of therapy[29] - The company has received multiple NDA approvals for its product, Xivio® (Selinexor), in various regions, including approvals in 2021, 2022, and upcoming approvals in 2024 and 2025[44] Cost Management - Sales and distribution expenses decreased by 61.5% from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of Selinexor in the Asia-Pacific region[7] - Administrative expenses fell by 28.2% from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[7] - Research and development costs decreased to RMB 258,912,000 in 2024 from RMB 405,669,000 in 2023, reflecting a 36.3% reduction[45] - Selling and distribution expenses dropped from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, mainly due to the absence of milestone payments and reduced employee costs[94] - Employee costs decreased from RMB 77.5 million in 2023 to RMB 20.5 million in 2024, representing a decline of about 73.5%[96] Market Expansion and Strategy - The company is focusing on expanding its market presence in Greater China, South Korea, Singapore, Malaysia, Indonesia, Vietnam, Laos, Cambodia, the Philippines, Thailand, and Mongolia[22] - The company is exploring new strategies for commercialization and market expansion[22] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[15] - The company is preparing its commercial team for the launch of Xivio® in the Asia-Pacific region to address unmet medical needs[44] Financial Position - The total assets less current liabilities amounted to RMB 1,198,407,000 in 2024, down from RMB 1,427,699,000 in 2023[48] - Cash and bank balances decreased to RMB 900,138,000 in 2024 from RMB 1,187,703,000 in 2023, indicating a liquidity reduction[48] - The company’s total equity decreased to RMB 850,801,000 in 2024 from RMB 1,147,384,000 in 2023, reflecting a decline in shareholder value[48] - The debt-to-asset ratio increased to 36.7% in 2024 from 29.1% in 2023, indicating a rise in leverage[105] Corporate Governance - The audit committee, consisting of three independent non-executive directors, has reviewed the financial performance and confirmed compliance with relevant accounting standards and regulations[120] - The company has maintained a public float of at least 25% of its total issued share capital in accordance with listing rules[124] - The company has adopted the "Standard Code" for securities trading by directors and confirmed compliance throughout the reporting period[114] - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[113]
德琪医药-B(06996) - 2024 - 年度业绩