AKESO(HK:09926)2023-09-26 09:37Company Overview - Akeso, Inc. has over 30 innovative projects in development, with 19 in clinical trials, including 3 commercialized products and 4 licensed products[15]. - The company aims to develop first-in-class or best-in-class therapies, focusing on oncology, autoimmune, and metabolic diseases[15]. - Akeso's TETRABODY technology addresses three major CMC challenges in developing and producing bispecific antibodies[15]. Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 3,676.9 million, a significant increase of 2,154.4% compared to RMB 163.1 million for the same period in 2022, primarily driven by product sales and licensing fees[26]. - Gross profit for the same period was RMB 3,599.7 million, up 2,566.4% from RMB 135.0 million year-over-year, mainly due to a substantial increase in licensing fee income[27]. - Profit for the six months ended June 30, 2023, was RMB 2,489.5 million, a turnaround from a loss of RMB 691.9 million in the same period of 2022, representing a year-over-year growth of 459.8%[28]. - The company recorded a profit of approximately RMB 2,489.5 million for the reporting period, marking its first half-year profit, compared to a loss of RMB 691.9 million for the same period in 2022[29]. - Product sales for the reporting period amounted to RMB 794.7 million, with the innovative drug 开坦尼® (卡度尼利) contributing RMB 605.8 million to this total[30]. - The company confirmed RMB 2,915.2 million as licensing fee income from the collaboration agreement for the dual antibody drug 依沃西 (AK112) with Summit Therapeutics, significantly boosting its cash reserves[31]. - License fee income for the six months ended June 30, 2023, was RMB 2,919.0 million, up from zero in the same period of 2022, primarily due to a collaboration agreement for the dual antibody drug[91]. - Other income and gains for the six months ended June 30, 2023, amounted to RMB 380.1 million, a 400.1% increase from RMB 76.0 million in the same period of 2022, mainly due to foreign exchange gains and government subsidies[95]. - The company’s total comprehensive income for the six months ended June 30, 2023, was RMB 2,498.2 million, compared to a loss of RMB 611.8 million in the same period of 2022[93]. Clinical Development and Product Pipeline - The company has over 30 innovative projects in development, with 19 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[37]. - The clinical development of 依沃西 is being efficiently advanced in collaboration with Summit, with the first patient dosed in the U.S. for a global Phase III trial[33]. - The company is actively preparing for the commercialization of 伊努西单抗 (AK102) and 依若奇单抗 (AK101), with new drug applications accepted by the CDE[36]. - The innovative product AK102 (PCSK9) for metabolic diseases received acceptance for its new drug application in June 2023[39]. - The company has a rich pipeline in autoimmune diseases, with AK101 (IL-12/IL-23) receiving acceptance for its new drug application in August 2023[39]. - The company is focusing on expanding its market presence through the combination of its dual antibodies Katanin and AK112, aiming for broader market coverage[38]. - The company is actively pursuing clinical research for other products, including AK111 (IL-17) and AK120 (IL-4R)[39]. - The company is exploring various combination therapies for its core products, targeting multiple cancer types and stages[41]. - The company aims to leverage its innovative therapies to address a wide range of indications, including solid tumors and hematological malignancies[38]. - The company is committed to advancing its clinical research and product development to enhance its competitive position in the oncology market[41]. Collaborations and Partnerships - The company is collaborating with Rongpu Biotechnology for the development of its licensed product, Puyuheng (PD-1)[39]. - The company achieved a significant milestone in March by entering into a collaboration with Lixin Pharmaceutical to advance the development of AK112 combined with Lixin's LM-302 for related solid tumors[52]. - In March, the company partnered with Shanghai Pharmaceuticals to advance the development of Cardonili combined with SPH4336 for high-grade liposarcoma and dedifferentiated liposarcoma[46]. Clinical Trials and Approvals - The company completed enrollment for a key Phase III clinical trial of Cardonili combined with chemotherapy for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in March[46]. - In April, the company received CDE approval for a Phase II clinical trial of Cardonili combined with AK117 for neoadjuvant treatment of gastric or gastroesophageal junction adenocarcinoma[46]. - In June, two-year follow-up data for Cardonili combined with chemotherapy for gastric or gastroesophageal junction adenocarcinoma was presented at the 2023 ASCO annual meeting[48]. - The company received CDE approval in July for a Phase III clinical trial comparing Cardonili combined with chemotherapy against Tislelizumab combined with chemotherapy for PD-L1 negative locally advanced or metastatic NSCLC[49]. - In June, Phase II clinical data for AK112 combined with chemotherapy for EGFR/ALK negative advanced or metastatic NSCLC was presented at the 2023 ASCO annual meeting[54]. - The company initiated a Phase III clinical trial in May comparing AK112 combined with chemotherapy against Tislelizumab combined with chemotherapy for squamous NSCLC[52]. - The company completed patient enrollment for a Phase III clinical trial in August comparing AK112 monotherapy against Pembrolizumab monotherapy for PD-L1 positive NSCLC[55]. Employee and Operational Metrics - The company has a total employee count of 2,520 as of June 30, 2023, an increase from 2,289 on June 30, 2022, reflecting a growth of approximately 10.1%[81]. - The company has a total operational capacity of 54,000 liters, with ongoing expansion plans to meet future clinical and commercialization needs[82]. Shareholder Information and Corporate Governance - As of June 30, 2023, the total number of issued shares was 841,057,176, with significant shareholdings reported by various directors and entities[134]. - Dr. Xia Yu holds a total of 136,570,582 shares, representing approximately 16.24% of the issued shares, indicating substantial ownership[135]. - The company has received approval from the Stock Exchange to remove the "B" designation from its stock name effective March 28, 2023, due to the inapplicability of certain listing rules[131]. - The board of directors has undergone changes, with Mr. Tan Bo appointed as an independent non-executive director of Genting New Year Limited on January 19, 2023[132]. - The company has adopted corporate governance practices and complies with applicable codes, with the current structure allowing the same individual to serve as both Chairman and CEO[117]. Restricted Share Unit Plans - The company adopted a pre-IPO restricted share unit plan on August 29, 2019, to incentivize participants and attract talent for further development[146]. - A total of 45,270,499 shares are available for delivery under the pre-IPO restricted share unit plan[148]. - The plan allows participants to receive shares or cash equivalent to the market value of shares at the time of vesting, with a reward price set at RMB 1.00 per share[147]. - The 2021 Restricted Share Unit Plan is effective for ten years from December 6, 2021, with approximately 8 years and 3 months remaining as of the report date[186]. - The maximum number of shares involved in the rewards granted under the 2021 Restricted Share Unit Plan cannot exceed 10% of the total issued share capital during the trust period[187]. - The plan limits the maximum number of shares granted to any selected participant to 1% of the total issued share capital in any 12-month period[191]. - The plan prohibits granting rewards during specific periods, including 60 days prior to the annual results announcement and 30 days prior to the interim results announcement[191].