AKESO(09926)2024-09-30 08:46Product Development and Innovation - Akeso, Inc. has over 50 innovative projects in development, with 10 products in commercialization or Phase III clinical trials, including 4 approved products and 2 under NMPA review[2]. - The company has developed a Tetrabody technology to address three CMC challenges in developing and producing bispecific antibodies, including low expression levels and stability issues[2]. - Akeso aims to become a leading global biopharmaceutical company through efficient and innovative R&D, focusing on first-in-class and best-in-class bispecific antibodies[2]. - The company is advancing the Phase III clinical trial of Cardunili, focusing on its efficacy in various cancers, with over 20 clinical trials ongoing across 16 indications[14]. - The company is actively pursuing partnerships and collaborations to enhance its research and development capabilities[26]. - The company is focusing on tumor immunotherapy, with products in clinical trials including approved therapies and several bispecific antibodies targeting various indications[24]. - The company aims to address unmet medical needs in oncology through its diverse product pipeline[25]. - The company is advancing its product candidates into Phase Ib/III trials, indicating a strong commitment to clinical development[25]. - The company has submitted IND applications for three candidates: AK137 (CD73/LAG-3) for advanced malignancies, AK138D1 (HER3 ADC) for advanced malignancies, and AK135 (IL-1RAP) for chemotherapy-induced peripheral neuropathy[23]. Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 1,024.7 million, a decrease from RMB 3,676.9 million for the same period in 2023[8]. - Product revenue for the six months ended June 30, 2024, was RMB 939.4 million, up 23.96% from RMB 757.9 million in the same period last year[11]. - Gross profit for the six months ended June 30, 2024, was RMB 943.2 million, compared to RMB 3,599.7 million for the same period in 2023[9]. - The company recorded a loss of RMB 249.3 million for the six months ended June 30, 2024, compared to a profit of RMB 2,489.5 million for the same period in 2023[10]. - The significant decline in licensing revenue was primarily due to the change in the revenue structure, with licensing income dropping to RMB 85.3 million from RMB 2,919.0 million year-on-year[8]. - The company reported a total comprehensive loss of RMB 250,049 thousand for the six months ended June 30, 2024, compared to a total comprehensive income of RMB 2,498,155 thousand in the same period of 2023[161]. - The company reported a loss attributable to equity holders of RMB (238,590,000) for the six months ended June 30, 2024, compared to a profit of RMB 2,525,045,000 in the same period in 2023[189]. Product Sales and Revenue Sources - Sales of the product Kanti® (Cardunili, PD-1/CTLA-4) generated approximately RMB 705.7 million, an increase of 16.50% from RMB 605.8 million in the previous year[12]. - The main revenue source was from the product 开坦尼® (卡度尼利·PD-1/CTLA-4), which generated RMB 705.7 million, up 16.50% from RMB 605.8 million in the previous year[36]. - Other products contributed RMB 233.7 million, representing a significant increase of 53.66% from RMB 152.1 million[36]. - Revenue from mainland China was RMB 938,131,000, up 24% from RMB 756,189,000 in the previous year[180]. - Revenue from the United States significantly dropped to RMB 85,117,000 from RMB 2,920,093,000, indicating a decline of approximately 97%[180]. Clinical Trials and Regulatory Approvals - The new indication for Cardunili in combination with chemotherapy for advanced gastric cancer received acceptance from NMPA in January 2024[13]. - Cardunili's III phase clinical trial results for cervical cancer were positively reported in July 2024, achieving the primary endpoint in interim analysis[13]. - The product revenue for Yidafang (Yivofisi) reached approximately RMB 103 million during the reporting period, following its approval for use in treating EGFR-mutant NSCLC[15]. - The Phase III trial of Yivofisi against Pabrolizumab in NSCLC achieved positive results, marking it as the first and only monotherapy to do so, with a successful sNDA submission to CDE[16]. - The company has initiated multiple Phase III trials for Yivofisi, including combinations with chemotherapy for various cancers, demonstrating its potential as a cornerstone in tumor immunotherapy[16]. - Anika (Pianpuli) received NMPA approval for treating recurrent/metastatic nasopharyngeal carcinoma, with an sNDA for its combination therapy currently under review[18]. - The Phase III trial of Prolaxi (AK109) in combination with Cardunili for advanced G/GEJ cancer has commenced, with initial patient enrollment reported[19]. Employee and Operational Growth - The total number of employees as of June 30, 2024, is 2,815, an increase from 2,520 as of June 30, 2023, reflecting a growth of approximately 11.7%[30]. - The workforce in the clinical department has increased to 661 employees, up from 642 in the previous year, indicating a growth of approximately 2.9%[31]. - The production, quality assurance, and quality control workforce has grown to 686 employees, an increase of 19.3% from 575 in the previous year[31]. - The company has a total production capacity of 54,000 liters as of June 30, 2024, with plans for continuous expansion to meet future clinical and commercialization needs[32]. Cash Flow and Financial Position - Cash and cash equivalents as of June 30, 2024, amounted to RMB 2,487,349 thousand, up from RMB 1,542,313 thousand as of December 31, 2023, reflecting an increase of 61.1%[162]. - The company reported a net increase in cash and cash equivalents of RMB 926,402,000 for the six months ended June 30, 2024, down from RMB 2,084,516,000 in 2023, a decrease of approximately 56%[169]. - The net cash flow from operating activities for the six months ended June 30, 2024, was (RMB 346,503,000), a significant decrease from RMB 2,871,241,000 in the same period of 2023, indicating a decline of approximately 112%[169]. - The company recognized licensing income of RMB 85,318,000 in the first half of 2024, a significant drop from RMB 2,918,988,000 in the same period of 2023, indicating a decrease of approximately 97%[175]. Corporate Governance and Compliance - The company has confirmed compliance with the standard code of conduct for securities trading by all directors during the reporting period[55]. - The company has adopted and complied with all applicable code provisions of the corporate governance code, except for the separation of the roles of Chairman and CEO[54]. - The company plans to review and monitor its corporate governance practices continuously to maintain high standards[54]. - There were changes in the board of directors, with Dr. Xia Yu resigning as an executive director and Dr. Zhang Peng appointed as an executive director[64]. Shareholder Information and Stock Options - The total number of issued shares as of June 30, 2024, is 865,857,176 shares[68]. - Major shareholders owning 5% or more of the issued shares include Cantrust (Far East) Limited with 47,664,282 shares (5.50%) and YAO Yulin with 43,453,668 shares (5.02%) as of June 30, 2024[71]. - The company has established a stock option plan that allows participants to exercise their options under specific conditions, including performance targets[135]. - The stock option plan allows for a maximum exercise period of 10 years from the grant date[135]. - The company will ensure compliance with listing rules and regulations regarding the stock option plan[134].