Financial Performance - For the year ended December 31, 2022, the total revenue of the group was approximately RMB 1,453 million, a decrease of about 64% compared to the same period in 2021, primarily due to a reduction in overseas licensing income [2]. - The loss attributable to owners of the company was RMB 2,386 million, an increase of RMB 1,667 million compared to the same period in 2021, primarily due to decreased licensing income [3]. - The net loss for the year was RMB 2,582,095 thousand, compared to a net loss of RMB 728,181 thousand in 2021, representing a significant increase in losses [91]. - Basic and diluted loss per share for the year was RMB 2.60, compared to RMB 0.80 in 2021 [91]. - The total comprehensive expenses for the year ended December 31, 2022, amounted to RMB (2,650,714) thousand, a significant increase from RMB (718,579) thousand in 2021, reflecting a rise of approximately 269% [65]. - The adjusted total comprehensive expenses for the year ended December 31, 2022, were RMB (2,608,855) thousand, compared to RMB (485,888) thousand in 2021, indicating an increase of around 437% [65]. Revenue Sources - Sales revenue from Tuoyi® (Tirzepatide) was approximately RMB 736 million, an increase of about 79% compared to the same period in 2021, driven by enhanced commercialization capabilities and the approval of two new indications [2]. - Pharmaceutical revenue was approximately RMB 753 million, an increase of about 76% year-on-year, primarily due to enhanced commercialization capabilities and the approval of two new indications for the product Tuoyi® [59]. - The company recognized license income of RMB 221,508,000 from Coherus and RMB 254,967,000 from sales sharing agreements for the year ended December 31, 2022 [101]. Research and Development - Research and development expenses totaled approximately RMB 2,384 million, an increase of about 15% compared to 2021, due to increased investment in R&D and the rapid advancement of existing clinical projects [2]. - The company has expanded its innovative R&D pipeline to include small molecules, peptides, antibody-drug conjugates, and nucleic acid drugs, covering five major therapeutic areas [4]. - The company is actively expanding its product pipeline, including small molecule drugs, peptide drugs, and next-generation innovative therapies targeting cancer and autoimmune diseases [11]. - The company plans to enhance its R&D pipeline by focusing on large molecule drug development and exploring new drug targets in small molecule research [58]. - The company plans to continue investing in R&D to drive future growth and innovation in drug development [96]. Clinical Trials and Approvals - As of the announcement date, four drugs have been commercialized in China or overseas, with nearly 30 drugs in clinical trials, including three in Phase III trials [4]. - The IND application for JS112 (Aurora A inhibitor) was approved by the NMPA in February 2022, indicating progress in the company's pipeline [4]. - The company achieved statistical superiority in a Phase III clinical study of Mindewi® for early treatment of COVID-19, with results published in a prestigious journal [5]. - The IND application for JS401, a small interfering RNA targeting ANGPTL3 mRNA, developed in collaboration with Runjia (Shanghai) Pharmaceutical Technology Co., Ltd., was accepted by the NMPA in January 2023 [8]. - The company is conducting multiple Phase Ib/II clinical trials for its first-in-human anti-tumor anti-BTLA monoclonal antibody, tifcemalimab, which has received IND approval from both FDA and NMPA [10]. Financing and Cash Flow - Net cash inflow from financing activities was RMB 4,643 million, mainly from the issuance of new A-shares and new bank loans, which increased cash reserves by RMB 2,492 million [3]. - Cash and cash equivalents increased from approximately RMB 3,505 million as of December 31, 2021, to approximately RMB 5,997 million as of December 31, 2022, primarily due to the completion of a new A-share issuance [63]. - The company raised approximately RMB 4,836 million from the A-share public offering, with net proceeds of about RMB 4,497 million after deducting issuance costs [68]. - Cash flow from financing activities included CNY 840,362,035.97 in borrowings received in 2022, up from CNY 500,000,000.00 in 2021, indicating a growth of 68.1% [133]. Market Presence and Commercialization - The company has established a commercialization team of nearly 1,000 people to enhance market presence and sales capabilities [11]. - Tuoyi® has been included in the National Medical Insurance Catalog for three indications, providing broader access to patients and reducing their medication burden [11]. - The company has successfully expanded Tuoyi® sales to over 4,000 medical institutions and approximately 2,000 pharmacies across China [26]. - The company is focusing on expanding its market presence in Southeast Asia and other regions through strategic partnerships [25]. Collaborations and Partnerships - The company signed a collaboration agreement with Coherus BioSciences, receiving an upfront payment of $35 million and potential milestone payments up to $255 million for the development of TAB006/JS006 in the U.S. and Canada [7]. - The company has entered into multiple collaborations, including a $35 million upfront payment from Coherus for the development of TAB006/JS006, with potential milestone payments up to $255 million [17]. - The company has entered into a shareholder agreement to acquire a 40% stake in Excellmab, with potential milestone payments of up to approximately $4.52 million, plus royalties based on net sales [9]. Regulatory and Compliance - The company has adhered to the corporate governance code as per Hong Kong listing rules during the reporting period [87]. - The company is committed to compliance with regulatory changes to mitigate policy risks and ensure operational adaptability [80]. - The company has received government subsidies related to R&D activities amounting to RMB 32,738,000 in 2022, down from RMB 89,061,000 in 2021 [104]. Risks and Challenges - The company faces risks related to prolonged non-profitability due to high R&D costs and market promotion expenses, which may lead to uncertainty in future profitability [74]. - The company is exposed to foreign exchange risks from holding foreign currency assets and liabilities, which may impact operating performance due to currency fluctuations [79].
君实生物(01877) - 2022 - 年度业绩