AKESO(09926)2024-04-29 14:30Pipeline and Clinical Development - Akeso has over 50 innovative projects in the pipeline, covering oncology, autoimmune, and metabolic diseases, with 19 in clinical trials, including 6 potential global first-in-class or best-in-class bispecific antibodies[15] - The company has 3 drugs in the commercialization phase and 8 registration clinical studies reaching primary endpoints in 2023, including the global first-in-class bispecific antibody PD-1/VEGF (Ivonescimab) and PD-1/CTLA-4 (Cadonilimab)[21] - There are 12 ongoing registrational Phase III clinical studies for the two core bispecific antibodies, Ivonescimab and Cadonilimab[22] - Ivonescimab's NDA for advanced lung cancer was submitted and granted priority review, with potential approval expected in 2024[23] - Cadonilimab's NDA for first-line treatment of advanced gastric cancer was accepted in January 2024, showing superior clinical efficacy regardless of PD-L1 expression status[23] - The company has 4 first-in-class/best-in-class bispecific antibodies in clinical development and over 80 combination therapy studies ongoing[23] - AK112 (PD-1/VEGF) reached primary endpoints in Phase III trials for NSCLC, with NDA submitted and accepted for priority review by NMPA in 2023[31] - Global Phase III trials for AK112 in NSCLC, including HARMONi and HARMONi-3, have commenced patient enrollment, accelerating global clinical development[32] - The company has 3 self-developed innovative products commercialized and 3 additional products under NDA review by NMPA[29] - Annike® (penpulimab, PD-1) received NMPA approval in January 2023 for first-line treatment of locally advanced or metastatic squamous NSCLC, and the company submitted an sNDA in December 2023 for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)[33] - The company submitted NDAs for Inusirumab (AK102, PCSK9) in June 2023 for primary hypercholesterolemia and mixed hyperlipidemia, and for Eruxizumab (AK101, IL-12/IL-23) in August 2023 for moderate-to-severe plaque psoriasis[33] - As of December 31, 2023, the company had over 50 innovative projects in its pipeline, with 19 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[34] - The company is conducting clinical trials for multiple products, including Kadunili (PD-1/CTLA-4), Ewuxi (AK112, PD-1/VEGF), and Annike® (penpulimab, PD-1), covering a wide range of indications in solid tumors and hematologic malignancies[35] - The company submitted NDAs for Inusirumab (AK102, PCSK9) in June 2023 and Eruxizumab (AK101, IL-12/IL-23) in August 2023, and is actively preparing for their commercialization[36] - The company is advancing clinical research and exploration for other products, including Gumoximab (AK111, IL-17) and Mandoximab (AK120, IL-4Rα)[36] - The company's clinical development plan includes global experiments, market approvals, registration clinical trials, and breakthrough therapies, with significant progress in tumor immunotherapy and other therapeutic areas[37] - AK105 (PD-1) combined with AK112 and AK104 is being developed for advanced solid tumors[38] - AK104-302 Phase III trial for G/GEJ adenocarcinoma met the primary endpoint of overall survival (OS) in interim analysis[42] - AK104-303 Phase III trial for cervical cancer met the primary endpoint of progression-free survival (PFS) in interim analysis[42] - AK102 (PCSK9) NDA submitted in June 2023 for familial hypercholesterolemia[40] - AK101 (IL-12/IL-23) NDA submitted in August 2023 for moderate to severe plaque psoriasis[40] - AK120 (IL-4Rα) is in Phase II trials for moderate to severe atopic dermatitis[40] - AK104 combined with chemotherapy completed enrollment for Phase III trial in G/GEJ adenocarcinoma in March[41] - AK104 combined with SPH4336 (CDK4/6 inhibitor) is being developed for WDLS/DDLS tumors[41] - AK104 combined with AK117 received NMPA approval for Phase II trial in G/GEJ adenocarcinoma in April[41] - AK104 combined with chemotherapy received NMPA approval for Phase II trial in pancreatic cancer in May[41] - Kadunilizumab's new indication for first-line treatment of G/GEJ adenocarcinoma was accepted by NMPA in January 2024[45] - Ivonescimab (AK112) combined with LM-302 for advanced gastrointestinal tumors entered clinical studies in March 2023[46] - Ivonescimab's Phase III HARMONi trial for EGFR-mutated NSCLC achieved first patient dosing in the US in May 2023[46] - Ivonescimab's Phase III trial for squamous NSCLC completed patient enrollment in August 2023[46] - AK117's Phase II trial for high-risk MDS was approved by FDA in September 2023[49] - AK117's Phase II trial for AML was approved by NMPA in January 2024[51] - AK102's NDA for hypercholesterolemia was accepted by NMPA in June 2023[58] - AK101's Phase III trial for plaque psoriasis met primary endpoints in February 2023[61] - AK111's Phase III trial for plaque psoriasis achieved all efficacy endpoints in December 2023[63] - The company is conducting over 20 clinical trials for its core bispecific antibody product cadonilimab, covering 16 indications including gastric cancer, liver cancer, and lung cancer[70] - AK120 (IL-4Rα) completed Phase II clinical trial enrollment for moderate-to-severe atopic dermatitis in March 2023[65] - The company has four self-developed bispecific antibody products (AK129, AK130, AK131, AK132) in clinical stages, targeting various solid tumors[70] - Production and commercialization preparations are underway for AK102 (PCSK9) and AK101 (IL-12/IL-23) in the non-oncology sector[71] Financial Performance - Total revenue for 2023 reached RMB 4,526.3 million, a 440% increase compared to RMB 837.7 million in 2022[25][28] - Product sales for 2023 amounted to RMB 1,631.1 million, with Kadunili (PD-1/CTLA-4) sales reaching RMB 1,357.8 million, a 149% increase from RMB 546.3 million in 2022[25][28][29] - Technology licensing and collaboration income for 2023 was RMB 2,922.8 million, largely due to the upfront payment from Summit Therapeutics for AK112 (PD-1/VEGF) licensing[25][28] - Gross profit for 2023 was RMB 4,393.0 million, a 491% increase from RMB 743.5 million in 2022, driven by significant growth in technology licensing and collaboration income[26] - The company recorded a net profit of RMB 1,942.4 million in 2023, compared to a net loss of RMB 1,422.2 million in 2022[27][28] - Total product market sales for the year ended December 31, 2023, reached RMB 1,631.1 million, a 48% increase compared to RMB 1,104.4 million in 2022, driven by strong sales of Cadonilimab (PD-1/CTLA-4) and other products[73] - Cadonilimab (PD-1/CTLA-4) sales for 2023 were RMB 1,357.8 million, a 149% increase from RMB 546.3 million in 2022, contributing significantly to the overall growth[74] - Technology licensing and collaboration income surged to RMB 2,922.8 million in 2023, up from RMB 3.9 million in 2022, primarily due to upfront payments from the Summit collaboration for AK112 (PD-1/VEGF)[76] - Gross profit for 2023 was RMB 4,393.0 million, a 491% increase from RMB 743.5 million in 2022, largely driven by the significant rise in technology licensing income[78] - Other income and net gains for 2023 were RMB 454.2 million, a 186% increase from RMB 158.6 million in 2022, mainly due to foreign exchange gains and interest income[80] - R&D expenses for 2023 decreased by 5% to RMB 1,254.0 million from RMB 1,323.1 million in 2022, as the company internalized some clinical services[81] - Sales and marketing expenses increased by 61% to RMB 890.4 million in 2023, up from RMB 552.7 million in 2022, driven by marketing activities for Cadonilimab[83] - The company reported a net profit of RMB 1,942.4 million for 2023, compared to a net loss of RMB 1,422.2 million in 2022[86] - As of December 31, 2023, the company's cash and cash equivalents, fixed deposits, and financial products totaled RMB 4,894.4 million, a significant increase from RMB 2,288.4 million in 2022[87] - Total employee count increased to 2,778 in 2023, up from 2,341 in 2022, with significant growth in clinical (679 vs. 532) and sales & marketing (788 vs. 652) functions[96] - Total employee compensation costs rose to RMB 847.1 million in 2023, up from RMB 624.1 million in 2022, driven by increased headcount[96] - Capital commitments decreased to RMB 770.0 million in 2023 from RMB 981.1 million in 2022, primarily due to progress in production and R&D facilities in Zhongshan and Guangzhou[97] - The company's quick ratio improved significantly to 4.39 in 2023 from 2.0 in 2022, indicating stronger liquidity position[89] - Total assets pledged as collateral amounted to RMB 793.3 million as of December 31, 2023, securing loans and bank credit facilities[89] - The 2021 placement proceeds of HKD 1,171.3 million (RMB 978.1 million) were fully utilized by December 31, 2023, with 40% allocated to commercialization team establishment and talent retention[99] - R&D employee count increased to 320 in preclinical and 679 in clinical functions in 2023, up from 275 and 532 respectively in 2022[96] - Production, quality assurance, and quality control staff grew to 687 in 2023 from 605 in 2022, reflecting capacity expansion efforts[96] - The company maintains no significant foreign exchange risk, with most transactions settled in RMB and partial cash holdings in HKD and USD[95] - No significant contingent liabilities or major investments were reported as of December 31, 2023[91][93] - The net proceeds from the 2022 placement amounted to approximately 576.66 million), with 40% allocated to the marketing and commercialization of Cadonilimab (AK104, PD-1/CTLA-4), totaling HK115.3 million) were allocated to accelerate the Phase III clinical trials of Ivonescimab (AK112, PD-1/VEGF), including head-to-head trials with Keytruda for 1L PD-L1(+) NSCLC[101] - 20% of the 2022 placement proceeds (HK57.7 million) were allocated to accelerate Phase III trials and NDA applications for Inclisiran (AK102, PCSK9) and Ebdarokimab (AK101, IL-12/IL-23), with HK16.7 million remaining unused[101] - The remaining unused net proceeds of approximately HK149.53 million (HK47.68 per share, representing a 6.02% discount to the last closing price before the placement agreement[103] - 65% of the 2024 placement proceeds will be allocated to R&D, including IND-stage preclinical projects, ADC platform development, and global clinical trials for Cadonilimab (AK104) and Leflunomide (AK117, CD47)[103] - 25% of the 2024 placement proceeds will be used for the commercialization of Cadonilimab and Ivonescimab, while 10% will be allocated for general corporate purposes[103] - The company expects to utilize the 2024 placement proceeds by December 31, 2025, based on current market conditions and operational needs[104] - Total revenue for the year ended December 31, 2023, was RMB 4,526.3 million, including total sales from products and license income of RMB 4,553.9 million, minus distribution costs of RMB 27.6 million[148] - Sales from the top five customers accounted for approximately 75.4% of the company's total revenue in 2023, compared to 29.7% in 2022[148] - The largest customer, SUMMIT, accounted for approximately 64.8% of the company's total revenue in 2023, up from 14.1% in 2022[148] - Purchases from the top five suppliers accounted for approximately 26.2% of the company's total purchases in 2023, down from 30.3% in 2022[149] - The largest supplier accounted for approximately 8.1% of the company's total purchases in 2023, down from 11.0% in 2022[149] - The company made charitable donations of approximately RMB 23.6 million in 2023, compared to RMB 11.8 million in 2022[160] - The company's distributable reserves as of December 31, 2023, were RMB 5,143,796,000, compared to RMB 5,169,255,000 in 2022[165] - The company did not declare a final dividend for the year ended December 31, 2023[163] - The company did not issue any debentures during the year ended December 31, 2023[161] - The company did not provide any financial assistance or guarantees to its affiliates during the year ended December 31, 2023[156] - The company's bank loans and other borrowings as of December 31, 2023, are detailed in the financial statements, with no significant seasonal borrowing requirements[166] Technology and Innovation - The company has developed the Tetrabody technology, which addresses three CMC challenges in bispecific antibody development: low expression levels, process development obstacles, and antibody stability and druggability[15] - The company's ACE platform integrates end-to-end drug discovery and development functions, including target validation, antibody discovery and development, CMC process development, and GMP-compliant manufacturing[15] - The company has expanded its R&D into ADC technology, mRNA technology, and cell therapy to maintain long-term global competitive advantage[24] - The company is proactively developing multiple proprietary technology platforms, including ADC, cell therapy, and mRNA, to efficiently advance more candidate molecules to the clinical stage[36] Commercialization and Sales - Akeso has 31 commercialized products and 42 externally licensed products, including AK107 (CTLA-4) licensed to Merck, AK105 (PD-1) licensed to Lepu Biotech, and AK112 (PD-1/VEGF) licensed to SUMMIT[15] - Akeso's key products include Cadonilimab (PD-1/CTLA-4), Penpulimab (PD-1), and Pucotenlimab (PD-1), which is licensed to Lepu Biotech[15] - Cadonilimab achieved sales of RMB 1.36 billion in 2023, with cumulative sales exceeding RMB 1.9 billion within 18 months of launch[21] - Annike® (penpulimab, PD-1) was included in multiple clinical authoritative recommendations and regional惠民保 catalogs in 2023, and the company expanded its indications to accelerate the transformation of clinical applications into commercial value[33] - In April 2023, the company signed a licensing agreement with Specialised Therapeutics Asia Pte Ltd (ST) for the exclusive sales rights of Annike® in Australia, New Zealand, Papua New Guinea, and 11 Southeast Asian countries[33] - The company's subsidiary, Tianqing Kangfang, entered into an exclusive sales agreement with Lianyungang Zhengda Tianqing for the sales of the monoclonal antibody product, with a fixed sales fee rate of no less than 35%[131][133] - The annual cap for sales and promotion services fees payable to Zhengda Tianqing by Tianqing Kangfang is RMB 2,500 million for 2023, with a cap of RMB 5,000 million for the sales of monoclonal antibody products[134] - The actual sales and promotion services fees paid by Tianqing Kangfang to Zhengda Tianqing during the reporting period were RMB 120,000, and the revenue from the sales of monoclonal antibody products was RMB 117.116 million, both within the 2023 annual cap[134] Organizational and Leadership - The company's organizational capabilities in strategic planning, R&D efficiency, and commercialization have been key to its rapid growth over 11 years[24] - The company's board consists of four executive directors, two non-executive directors, and three independent non-executive directors[105] - Dr. Xia Yu holds a Ph.D. in Molecular Biology and Microbiology from Newcastle University, UK, and has extensive experience in cancer immunotherapy research[108] - Dr. Li Baiyong, co-founder and Chief Scientific Officer, has over 24 years of experience in therapeutic biologics, including leadership roles at Pfizer Inc[