AKESO(HK:09926)2024-03-18 14:52Financial Performance - For the fiscal year ending December 31, 2023, the total revenue of the company was RMB 4,526.3 million, a significant increase of 440% compared to RMB 837.7 million for the fiscal year ending December 31, 2022[4]. - The company reported a gross profit of RMB 4,393.0 million for the fiscal year ending December 31, 2023, up 491% from RMB 743.5 million in the previous year, primarily due to substantial growth in technology licensing and collaboration revenue[4]. - The company achieved a profit of RMB 1,942.4 million for the fiscal year ending December 31, 2023, a significant turnaround from a loss of RMB 1,422.2 million in the previous year[6]. - The total comprehensive income after deducting distribution costs for the year ended December 31, 2023, was RMB 4,526.3 million, compared to RMB 837.7 million in the previous year, reflecting a significant increase[58]. - The gross profit for the year ended December 31, 2023, was RMB 4,393.0 million, with a gross profit margin of 97.06%, up from 88.76% in the previous year[58]. - The company reported a pre-tax profit of RMB 1,942.5 million for the year ended December 31, 2023, compared to a loss of RMB 1,422.2 million in the previous year[58]. - The overall comprehensive income for the year ended December 31, 2023, was RMB 1,936.5 million, compared to a loss of RMB 1,293.6 million in the previous year[58]. - The company reported a net profit attributable to shareholders of RMB 2,028,300 thousand in 2023, a substantial increase from a loss of RMB 1,168,393 thousand in 2022[102]. - Basic earnings per share for 2023 was RMB 2.42, a recovery from a loss of RMB 1.42 per share in 2022[102]. Revenue Sources - The annual product sales amounted to approximately RMB 1,631.1 million, with the product Kantonin® (Cardinili, PD-1/CTLA-4) generating sales of RMB 1,357.8 million, reflecting a 149% increase from RMB 546.3 million in the previous year[6]. - The annual technology licensing and collaboration revenue was approximately RMB 2,922.8 million, mainly contributed by the upfront payment from Summit Therapeutics Inc for the licensing of AK112 (PD-1/VEGF)[6]. - The revenue from technology licensing and cooperation amounted to RMB 2,922,775,000 in 2023, compared to RMB 3,920,000 in 2022, indicating a substantial increase[114]. - Revenue from domestic customers in China was RMB 1,593,541,000 in 2023, up from RMB 837,656,000 in 2022, reflecting a growth of about 90%[120]. - Revenue from the United States reached RMB 2,931,509,000 in 2023, with no revenue reported in 2022, marking a new market entry[120]. Research and Development - The company has over 50 innovative projects in development, including 19 in clinical trials, with 6 being potential first-in-class or best-in-class bispecific antibodies[5]. - The company is focusing on tumor immunotherapy, with several products in clinical trials, including Cardunili and AK112, which are expected to cover a broad range of indications[20]. - The company has established multiple self-developed technology platforms, such as ADC, cell therapy, and mRNA, to explore a wide range of therapeutic areas[22]. - The company is actively advancing clinical research for other products, including AK111 (IL-17) and AK120 (IL-4R)[22]. - The company is conducting over 20 clinical trials for its core dual antibodies, Cardinili and Iwosi, covering 16 indications including gastric, liver, lung, cervical, esophageal squamous, and colorectal cancers, with 6 key Phase III trials ongoing[53]. Clinical Trials and Approvals - Cardunili achieved significant milestones in two Phase III clinical trials for gastric and cervical cancer, with the gastric cancer trial demonstrating long-term survival benefits and the submission of a new indication application expected in January 2024[10]. - The Phase III trial for AK112 (PD-1/VEGF) in NSCLC reached its primary endpoint in 2023, with the new drug application accepted for priority review in August 2023, marking a step towards commercialization[13]. - The company has successfully submitted NDAs for AK102 (PCSK9) and AK101 (IL-12/IL-23) in 2023, targeting hypercholesterolemia and moderate to severe plaque psoriasis, respectively[18]. - The company has received NDA acceptance for innovative products in the field of metabolic diseases, including AK102 (PCSK9) in June 2023 and AK101 (IL-12/IL-23) in August 2023[21]. - The company submitted sNDA for Pidilizumab and AK105 in China, targeting ≥3L nasopharyngeal carcinoma and 1L nasopharyngeal carcinoma, respectively[26]. Market Expansion and Strategy - The company aims to become a leading global biopharmaceutical enterprise through efficient and innovative R&D to develop first-in-class or best-in-class therapies[5]. - The company is actively promoting the hospital and commercial insurance access for Kantonin®, which is now included in 15 provinces and approximately 70 local commercial insurance products, significantly improving patient accessibility[9]. - The company has expanded the sales rights for Anikou in 11 Southeast Asian countries, enhancing its market presence[17]. - The company aims to leverage Cardunili and AK112 as cornerstone therapies to cover a wider market space through extensive combination strategies[20]. - The company is exploring market expansion opportunities, particularly in the oncology sector[149]. Financial Stability and Growth - As of December 31, 2023, the company's current assets totaled RMB 5,676.8 million, with cash and cash equivalents, time deposits, and financial products amounting to RMB 4,894.4 million, an increase of RMB 2,606.0 million from RMB 2,288.4 million as of December 31, 2022[71]. - The company's current liabilities as of December 31, 2023, were RMB 1,204.6 million, including trade payables of RMB 354.8 million and other payables of RMB 443.6 million[72]. - The group reported a current ratio of 4.39 as of December 31, 2023, compared to 2.0 in the previous year, indicating improved liquidity[78]. - The group has no significant contingent liabilities as of December 31, 2023, ensuring a stable financial position[77]. - The company plans to continue expanding its market presence and investing in new technologies to drive future growth[102]. Employee and Operational Growth - As of December 31, 2023, the total number of employees increased to 2,778, up from 2,341 in 2022, reflecting ongoing talent acquisition efforts[48]. - Total employee compensation costs for the group reached RMB 847.1 million for the year ended December 31, 2023, up from RMB 624.1 million for the year ended December 31, 2022, driven by an increase in employee numbers[82]. - The group has adopted various employee training programs to enhance staff knowledge and skills, supporting its operational growth[82]. Corporate Governance and Compliance - The board of directors does not recommend the declaration of a final dividend for the reporting period, consistent with the previous year[85]. - The company operates under the regulatory framework of the National Medical Products Administration (NMPA) in China, affecting its product approval processes[149]. - The company has established a clear revenue recognition policy based on the timing of customer acquisition of relevant technology rights, ensuring compliance with accounting standards[116].