AKESO(HK:09926)2026-03-26 14:33Financial Performance - For the fiscal year ending December 31, 2025, the total revenue of Akeso, Inc. was RMB 3,056.3 million, representing a year-on-year increase of 43.9% from RMB 2,123.9 million in 2024[7]. - The gross profit for the fiscal year ending December 31, 2025, was RMB 2,404.0 million, up 31.01% from RMB 1,834.9 million in 2024[8]. - The company reported a net loss of RMB 1,140.8 million for the fiscal year ending December 31, 2025, which included non-cash items such as a loss of RMB 324.8 million related to long-term equity investments[9]. - The adjusted Non-IFRS net loss for 2025 was RMB 584.7 million, with an adjusted Non-IFRS EBITDA loss of RMB 191.9 million[9]. - Revenue for the reporting period was approximately RMB 3,056.3 million, a 43.90% increase from RMB 2,123.9 million in the same period last year[13]. - The company reported a total net loss of RMB 1,166,824,000 for the year, compared to a net loss of RMB 494,503,000 in the previous year, indicating a significant increase in losses[114]. - Basic loss per share for 2025 is RMB 1.23, compared to RMB 0.60 in 2024, reflecting a deterioration in earnings performance[114]. Commercial Sales and Product Development - Commercial sales revenue for the fiscal year ending December 31, 2025, was RMB 3,033.1 million, a 51.48% increase from RMB 2,002.4 million in 2024, driven by new product approvals[7]. - The company successfully introduced two innovative bispecific antibodies into the National Reimbursement Drug List (NRDL), contributing to revenue growth[6]. - The company has over 50 innovative projects under research, covering areas such as tumors, autoimmune diseases, metabolism, and neurodegenerative diseases[12]. - The company has 27 products in the market or clinical research stages, with 12 in Phase III clinical trials and 15 in Phase I/II trials[12]. - Five self-developed commercialized drugs have received approval for 12 indications, all included in the 2025 version of the national medical insurance catalog, to be implemented in January 2026[14]. - The product IYINING® (Inepolog) has been approved for two indications in China, both included in the latest national medical insurance catalog[17]. - The product YIDAFANG® (Ivosidenib) has completed over 44 clinical studies, including 15 Phase III trials, with positive results in four Phase III trials covering multiple cancer types[16]. Research and Development - The company has established a comprehensive R&D platform focusing on innovative antibody drug development technologies, positioning itself competitively in the global biopharmaceutical market[11]. - Akeso, Inc. is advancing multiple new bispecific antibodies into clinical research, including ADCs and treatments for immune-related diseases[5]. - The company aims to enhance its financial performance while increasing R&D investments to support future growth[5]. - The company is actively expanding into cold tumors and has initiated multiple clinical studies covering colorectal cancer, pancreatic cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, and triple-negative breast cancer[22]. - The company is advancing multiple self-developed products in oncology, autoimmune diseases, and Alzheimer's disease, including AK139, AK152, and AK150, currently in Phase I and II clinical trials[64]. Clinical Trials and Approvals - The clinical study (AK112-306/HARMONi-6) for the combination therapy of Ivoris and Tarelizumab achieved the primary endpoint of progression-free survival (PFS) for sq-NSCLC, with results presented at the 2025 ESMO LBA[23]. - The international multicenter III phase clinical study (HARMONi) for Ivoris in treating NSCLC after third-generation EGFR-TKI therapy reached the PFS primary endpoint, with significant overall survival (OS) trends[24]. - The combination therapy of Ivoris and chemotherapy for PD-L1 negative TNBC entered the III phase clinical study (AK112-308), which received breakthrough therapy designation from NMPA in November 2025[26]. - The company has initiated nearly 20 combination clinical studies for Ivoris in China, focusing on various cancer types such as lung, gastric, and colorectal cancers[28]. - The company received FDA approval for the international multicenter Phase III clinical study (COMPASSION-37) of cardunili combined with chemotherapy for the treatment of unresectable or metastatic G/GEJ adenocarcinoma, officially launched in December 2025[34]. Financial Position and Assets - As of December 31, 2025, the company's current assets totaled RMB 11,277.3 million, with cash and cash equivalents amounting to RMB 9,171.6 million[87]. - The company's current liabilities as of December 31, 2025, were RMB 2,195.1 million, which included trade payables of RMB 451.8 million[87]. - The company had short-term and long-term loans totaling RMB 4,540.6 million, with short-term loans due within one year amounting to RMB 585.7 million[88]. - The company's total assets amounted to RMB 13,805,313,000 in 2025, compared to RMB 11,068,335,000 in 2024, reflecting an increase of approximately 24.9%[115]. - The company’s inventory increased to RMB 931,616,000 in 2025 from RMB 706,533,000 in 2024, showing a growth of about 31.7%[115]. Employee and Corporate Governance - As of December 31, 2025, the total number of employees has grown to 3,761, with significant increases in clinical research and development personnel to support the integrated platform strategy[57]. - The company has adhered to all corporate governance code provisions during the reporting period, except for provision C.2.1, which states that the roles of chairman and CEO should be separate[101]. - The company issued a total of 23,550,000 new shares at a price of HKD 149.54 per share on September 4, 2025, representing approximately 2.56% of the enlarged issued share capital post-placement[105]. Strategic Goals and Future Outlook - The company aims to become a global leader in biopharmaceuticals by focusing on innovative drug development and establishing an international standardized production system[13]. - The company is actively expanding its international development strategy, aiming to advance more self-developed innovative drugs in the global market[67]. - The company is focused on maximizing the global value of its core products, including Ivosidenib, which has shown significant clinical benefits in multiple Phase III studies[63].