AKESO(HK:09926)2022-09-28 09:06Drug Development and Innovation - Akeso has developed over 30 innovative drug candidates targeting major diseases, with 15 currently in clinical stages, including two first-in-class bispecific antibody drugs [18]. - The company has established an end-to-end drug development platform (ACE platform) that integrates drug discovery and development functions [18]. - Akeso's bispecific antibody development technology (TETRABODY technology) addresses three major CMC challenges, including low expression levels and stability issues [18]. - The company aims to become a leading global biopharmaceutical enterprise by developing innovative drugs that are either first-in-class or best-in-class [18]. - The company is actively developing new products, with three new drug candidates expected to enter clinical trials by the end of 2023 [22]. - The company is focusing on oncology as a key therapeutic area, with ongoing clinical trials for multiple products including AK104 and AK112 [31]. - The company aims to fill the treatment gap for advanced cervical cancer in China with its innovative therapies [33]. Financial Performance - The company reported a revenue of RMB 100 million for the six months ended June 30, 2022, representing a 20% increase compared to the same period last year [22]. - Total sales for the six months ended June 30, 2022, reached RMB 297.2 million, an increase of 26.8% compared to RMB 128.6 million for the same period in 2021 [27]. - Other net income rose to RMB 76.0 million, a growth of 16.7% from RMB 65.1 million in the previous year, primarily due to increased government subsidies [27]. - The adjusted total comprehensive loss for the period was RMB 585.6 million, an increase of RMB 264.3 million from RMB 321.3 million in the same period last year [28]. - The company reported a net loss of RMB 691,884 thousand for the six months ended June 30, 2022, compared to a net loss of RMB 446,163 thousand for the same period in 2021, representing an increase in loss of approximately 55% [145]. - The total comprehensive loss for the six months ended June 30, 2022, was RMB 611.75 million, compared to RMB 471.47 million for the same period in 2021, reflecting an increase of 29.7% [62]. Research and Development Expenditure - The R&D expenditure for the first half of 2022 was RMB 20 million, accounting for 20% of total revenue [22]. - R&D expenses increased to RMB 595.4 million, up RMB 31.9 million from RMB 563.5 million in the prior year, reflecting a strategic focus on advancing late-stage clinical projects [27]. - Research and development expenses increased to RMB 595,384,000 for the six months ended June 30, 2022, from RMB 563,518,000 in the same period of 2021, reflecting a rise of 5.7% [137]. Market Expansion and Strategic Initiatives - Market expansion efforts include entering two new international markets, aiming for a 15% market share in each by 2025 [22]. - The company has completed a strategic acquisition of a biotech firm for USD 50 million to enhance its R&D capabilities [22]. - The company plans to invest RMB 30 million in technology upgrades to improve production efficiency [22]. - The company has established partnerships with three leading hospitals to enhance clinical trial recruitment [22]. Shareholder and Corporate Governance - The board did not recommend an interim dividend for shareholders during the reporting period [72]. - The company confirmed compliance with the standard code of conduct for securities trading throughout the reporting period [73]. - The company has adopted and complied with all applicable provisions of the corporate governance code during the reporting period, except for the separation of the roles of Chairman and CEO [72]. Employee and Compensation Information - As of June 30, 2022, the total number of employees was 2,289, an increase from 1,202 in the previous year [44]. - Total compensation costs for the six months ended June 30, 2022, were RMB 255.5 million, slightly up from RMB 250.9 million for the same period in 2021, an increase of 1.8% [70]. - The total compensation paid to key management personnel for the six months ended June 30, 2022, was RMB 19,806,000, a significant decrease of 85.0% from RMB 131,864,000 in the same period of 2021 [200]. Cash Flow and Liquidity - Cash and cash equivalents decreased by RMB 420.9 million to RMB 2,220.7 million as of June 30, 2022, from RMB 2,641.6 million as of December 31, 2021 [64]. - The liquidity ratio (current ratio) was 2.4 as of June 30, 2022, down from 4.5 as of December 31, 2021, indicating a decrease in liquidity [66]. - The company experienced a net cash outflow from operating activities of RMB (580,675) thousand, compared to RMB (346,463) thousand in the prior year, indicating a worsening cash flow situation [145]. Share Issuance and Capital Management - The company issued shares amounting to RMB 992,028 thousand during the period, which is a significant capital raise [143]. - A total of 24,000,000 new shares were issued at a price of HKD 24.27 per share, representing approximately 2.85% of the enlarged issued share capital after the placement [132]. - The net proceeds from the global offering amounted to approximately HKD 2,894.1 million (equivalent to approximately RMB 2,647.2 million) [74]. Clinical Trials and Approvals - The company received NMPA approval for its first-in-class PD-1/CTLA-4 bispecific antibody, AK104, on June 29, 2022, for treating recurrent or metastatic cervical cancer [30]. - The company received NMPA approval in June for the new drug "Kaitanni" to treat recurrent or metastatic cervical cancer, marking it as the first dual immune checkpoint inhibitor approved in China [33]. - The company announced that the Phase III clinical study for "AK112" in treating unresectable hepatocellular carcinoma (HCC) received CDE approval in June [36].