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君实生物(688180) - 2022 Q3 - 季度财报
2022-10-30 16:00
Financial Performance - The company's revenue for Q3 2022 was approximately RMB 272.33 million, a decrease of 54.91% compared to the same period last year[4] - The net profit attributable to shareholders was a loss of RMB 682.32 million for the quarter, with a cumulative loss of RMB 1.59 billion year-to-date[4] - The basic earnings per share for Q3 2022 was -0.75 yuan, with a year-to-date figure of -1.75 yuan[4] - Revenue for the first three quarters of 2022 was RMB 1,218,381,861.73, down from RMB 2,718,396,641.58 in the same period of 2021, indicating a decrease of approximately 55.2%[15] - The company reported a net loss of RMB 5,983,314,584.38 for the first three quarters of 2022, compared to a loss of RMB 4,388,585,020.16 in the same period of 2021[15] - The net profit for Q3 2022 was -1,734,538,953.68 CNY, compared to -392,126,886.59 CNY in Q3 2021, indicating a significant increase in losses[18] - The total comprehensive income for Q3 2022 was -1,755,730,362.15 CNY, compared to -368,440,990.46 CNY in Q3 2021, reflecting a worsening financial position[18] - The company reported a total operating profit of -1,716,008,666.56 CNY in Q3 2022, compared to -288,543,144.54 CNY in Q3 2021, indicating a decline in operational performance[17] Research and Development - R&D investment totaled RMB 573.88 million in Q3 2022, representing 210.73% of the revenue, an increase of 132.03 percentage points year-on-year[5] - Research and development expenses rose to 1,636,118,643.63 CNY in Q3 2022, up from 1,422,572,326.73 CNY in the same period last year[17] Assets and Liabilities - The total assets at the end of the reporting period were RMB 9.58 billion, down 13.18% from the end of the previous year[5] - As of September 30, 2022, total assets amounted to RMB 9,581,031,208.80, a decrease from RMB 11,034,911,100.95 at the end of 2021[14] - Total current assets decreased to RMB 4,261,782,626.15 from RMB 5,844,891,453.12 year-over-year[14] - Cash and cash equivalents were RMB 3,064,825,595.33, down from RMB 3,506,637,890.39 at the end of 2021, representing a decline of approximately 12.6%[14] - Accounts receivable decreased significantly to RMB 289,586,600.85 from RMB 1,293,122,136.21, a drop of about 77.6%[14] - Inventory increased to RMB 537,280,841.89 from RMB 484,601,367.48, reflecting a growth of approximately 10.9%[14] - Total liabilities were RMB 2,676,684,562.28, compared to RMB 2,718,536,814.27 in the previous year[15] - The company's equity attributable to shareholders decreased to RMB 6,555,742,303.66 from RMB 7,945,095,398.41, a decline of about 17.5%[15] Cash Flow - The company reported a net cash flow from operating activities of -1.12 billion yuan year-to-date, indicating a decline in cash inflow compared to the previous year[4] - Operating cash flow for Q3 2022 showed a net outflow of -1,117,489,221.19 CNY, compared to -540,121,393.81 CNY in Q3 2021, indicating increased cash burn[19] - The company reported cash and cash equivalents of 3,001,414,742.11 CNY at the end of Q3 2022, down from 3,147,459,500.68 CNY at the end of Q3 2021[20] Sales Performance - The sales revenue from the product Tuoyi® (JS001) reached approximately RMB 218 million in Q3 2022, marking a continuous quarter-on-quarter growth[6] - The company has received approval for six indications for Tuoyi® in China, indicating significant growth potential in the domestic market[6] - Sales revenue from goods and services received in Q3 2022 was 2,109,423,813.08 CNY, a decrease from 2,584,764,961.17 CNY in Q3 2021[19] Shareholder Information - The total number of shareholders as of the report date was 35,996, with 35,988 being A-share holders and 8 being H-share holders[14] Financial Expenses - The company incurred financial expenses of -71,341,733.51 CNY in Q3 2022, a decrease from 5,094,540.11 CNY in Q3 2021[17] - The company raised 396,975,840.00 CNY from investments in Q3 2022, significantly lower than 2,121,734,262.98 CNY in Q3 2021[20]
君实生物(01877) - 2022 Q3 - 季度财报
2022-10-30 10:35
Financial Performance - Total revenue for Q3 2022 was approximately RMB 272.33 million, a decrease of 54.91% compared to the same period last year[5]. - Net profit attributable to shareholders for Q3 2022 was a loss of RMB 682.32 million, with a year-to-date loss of RMB 1.59 billion[5]. - The company reported a diluted earnings per share of -RMB 0.75 for Q3 2022, with a year-to-date figure of -RMB 1.75[7]. - Net loss for Q3 2022 was CNY -1,734,538,953.68, compared to a net loss of CNY -392,126,886.59 in Q3 2021, representing a significant increase in losses[20]. - Basic and diluted earnings per share for Q3 2022 were both CNY -1.75, compared to CNY -0.44 in Q3 2021[21]. - The company reported a total comprehensive loss of CNY -1,755,730,362.15 for Q3 2022, compared to a loss of CNY -368,440,990.46 in the same quarter of the previous year[21]. Research and Development - Research and development expenses totaled RMB 573.88 million in Q3 2022, representing 210.73% of total revenue, an increase of 132.03 percentage points year-on-year[7]. - Research and development expenses for Q3 2022 reached CNY 1,636,118,643.63, an increase of 15.0% from CNY 1,422,572,326.73 in Q3 2021[20]. Assets and Liabilities - Total assets as of the end of Q3 2022 were RMB 9.58 billion, a decrease of 13.18% from the end of the previous year[7]. - Total current assets as of September 30, 2022, amounted to approximately CNY 4.26 billion, a decrease of 27% from CNY 5.84 billion at the end of 2021[16]. - The total liabilities as of Q3 2022 amounted to CNY 2,676,684,562.28, slightly down from CNY 2,718,536,814.27 in the previous year[21]. - The total equity attributable to shareholders of the parent company was CNY 6,555,742,303.66, a decrease of 17.5% from CNY 7,945,095,398.41 in the same period last year[21]. Cash Flow - The net cash flow from operating activities for the year-to-date period was -RMB 1.12 billion, primarily due to a decrease in technical licensing income[10]. - The net cash flow from operating activities for the first three quarters of 2022 was -1,117,489,221.19 RMB, compared to -540,121,393.81 RMB in the same period of 2021, indicating a significant decline[22]. - Total cash inflow from financing activities in Q3 2022 was 1,166,482,145.95 RMB, down from 2,621,734,262.98 RMB in Q3 2021, reflecting a decrease of approximately 55%[23]. - The cash inflow from operating activities totaled 2,429,312,921.58 RMB in the first three quarters of 2022, down from 2,717,797,542.77 RMB in 2021, representing a decrease of approximately 10.6%[22]. Shareholder Information - The number of total common shareholders at the end of the reporting period was 35,996[14]. - The top 10 shareholders held a combined 70.63% of the total shares, with HKSCC NOMINEES LIMITED holding 24.03%[14]. Product Performance - The sales revenue from the product Tuoyi® (Tremelimumab) reached approximately RMB 218 million in Q3 2022, marking a continuous quarter-on-quarter growth[7]. - The company has received approval for six indications for Tuoyi® in China, indicating potential for significant revenue growth as more indications are approved[7]. Financial Data and Reporting - The company emphasizes that the financial data presented is unaudited and prepared according to Chinese accounting principles[4]. - The company has not disclosed any significant new strategies or product developments during the reporting period[15].
君实生物(01877) - 2022 - 中期财报
2022-09-29 08:30
Financial Performance - For the six months ended June 30, 2022, the total revenue of the company reached approximately RMB 946 million, with sales revenue from Tuoyi® (Tremelimumab) amounting to approximately RMB 298 million, an increase of about 195% compared to the second half of 2021[9]. - The net loss for the reporting period was RMB 998 million, an increase of RMB 1,009 million compared to the same period in 2021, mainly due to a decrease in licensing income[9]. - In the first half of 2022, the company's revenue was RMB 946,049 thousand, a decrease of 55% compared to RMB 2,114,448 thousand in the same period of 2021[14]. - Gross profit for the first half of 2022 was RMB 625,577 thousand, down 62% from RMB 1,650,506 thousand year-over-year[14]. - The company reported a net loss of RMB 998,360 thousand for the first half of 2022, compared to a profit of RMB 10,533 thousand in the same period of 2021, marking a significant decline[14]. - The total assets decreased by 10% to RMB 9,903,225 thousand as of June 30, 2022, from RMB 11,050,720 thousand at the end of 2021[14]. - The adjusted total comprehensive expenses for the period were approximately RMB (1,078,881) thousand, compared to RMB 97,527 thousand in the same period of 2021[86]. - The basic loss per share attributable to the owners of the company was RMB (911,329) thousand for the six months ended June 30, 2022, compared to a profit of RMB 10,534 thousand in the same period of 2021[88]. - The company reported a net cash outflow from operating activities of approximately RMB 458 million for the six months ended June 30, 2022[84]. Research and Development - The company's R&D expenses totaled approximately RMB 1,062 million, representing a year-on-year increase of about 12%, primarily due to increased clinical costs and talent acquisition[9]. - The company has expanded its innovative R&D areas to include small molecule drugs, peptide drugs, antibody-drug conjugates (ADCs), bispecific or multispecific antibody drugs, and nucleic acid drugs, covering five major therapeutic areas[9]. - The company has three commercially available drugs in China or overseas markets, with nearly 30 drugs in clinical trials, including four in Phase III trials[9]. - The company achieved statistical superiority in a Phase III clinical study of VV116 (JT001) for early treatment of COVID-19, providing strong evidence for symptom relief acceleration[10]. - The company is actively expanding its product pipeline to include small molecules, peptide drugs, antibody-drug conjugates, and nucleic acid drugs, targeting next-generation innovative therapies for cancer and autoimmune diseases[16]. - The company has initiated over 30 clinical studies for Tuoyi® covering more than 15 indications, including key registration trials for various cancers[20]. - The company is conducting Phase III clinical trials for JS002, a monoclonal antibody targeting PCSK9, in a broader patient population, including non-familial and heterozygous familial hypercholesterolemia[26]. - The company is currently in a significant R&D investment phase, with a focus on expanding its product pipeline and accelerating clinical trials domestically and internationally[129]. Product Approvals and Market Expansion - In February 2022, the IND application for JS112 (Aurora A inhibitor) was approved by NMPA[10]. - In March 2022, the company received NMPA approval for the marketing of Junmaikang® (Adalimumab) for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis[10]. - In April 2022, Tuoyi® received orphan drug designation from the FDA for the treatment of small cell lung cancer, marking the fifth such designation for Tuoyi®[10]. - The company received NMPA approval for the sNDA of Tuoyi® in May 2022, marking the fifth indication approved for this drug[11]. - The FDA accepted the BLA for Treprilizumab in July 2022, with a target review date set for December 23, 2022[13]. - The company plans to launch Tuoyi® in the U.S. in Q1 2023, pending FDA approval, making it the first and only tumor immunotherapy for nasopharyngeal carcinoma in the U.S.[21]. - Tuoyi® has been granted Breakthrough Therapy Designation (BTD) for certain indications, indicating its potential in the market[46]. - Tuoyi® received FDA orphan drug designation for small cell lung cancer, marking its fifth such designation, previously granted for mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, and esophageal cancer[48]. Financial Strategy and Capital Raising - The company plans to raise up to RMB 3.969 billion through the issuance of up to 70 million A-shares to fund innovative drug development and R&D projects[13]. - The company has committed capital expenditures of RMB 683 million for property, plant, and equipment as of June 30, 2022, reflecting a 3% increase from RMB 664 million as of December 31, 2021[98]. - The company has a total of RMB 3,003 million planned for various uses, with 100% of the funds accounted for as of June 30, 2022[150]. - The company raised approximately RMB 4,497 million from the A-share listing after deducting issuance costs, with the proceeds allocated according to the disclosed purposes[152]. Market Presence and Sales Performance - Core product Tuoyi® has been approved for five indications, with sales revenue in China reaching approximately RMB 298 million in the first half of 2022, a 212% increase compared to Q4 2021[19]. - Tuoyi® sales in Q2 2022 increased by approximately 70% compared to Q1 2022, despite disruptions from COVID-19 in April and May[19]. - The commercial team has grown to over 1,100 personnel, enhancing the brand presence of Tuoyi® across more than 4,000 medical institutions and nearly 2,000 pharmacies in China[43]. - The updated National Medical Insurance catalog includes Tuoyi® for multiple indications, providing broader access and reducing patient costs across 61 provinces and cities[18]. - The company aims to improve its financial situation by commercializing multiple indications and products, which will help in achieving profitability[129]. Risks and Challenges - The company faces risks associated with not being profitable due to high R&D and operational costs, which may lead to uncertainty in achieving profitability in the short term[129]. - The ongoing COVID-19 pandemic has delayed the progress of clinical trials, impacting the R&D and commercialization of the core product, Triplizumab[136]. - The company is exposed to foreign exchange risks due to holding foreign currency assets and liabilities, which may affect operating performance if exchange rates fluctuate significantly[137]. - The company faces operational risks related to the stability of supplier relationships and potential price increases in R&D services and raw materials[132]. Corporate Governance and Compliance - The company emphasizes high standards of corporate governance, adhering to the principles and code provisions of the corporate governance code as per Hong Kong listing rules[147]. - The audit committee consists of two independent non-executive directors and one non-executive director, overseeing financial reporting and internal controls[157]. - The report indicates that the company is compliant with the Securities and Futures Ordinance regarding the disclosure of interests[118].
君实生物(688180) - 2022 Q2 - 季度财报
2022-08-30 16:00
Financial Performance - The company has not achieved profitability in the first half of 2022, with increasing R&D expenses not covered by operating income[4]. - The company's operating revenue for the first half of the year was ¥946,048,587.10, a decrease of 55.26% compared to ¥2,114,448,449.63 in the same period last year[18]. - The net profit attributable to shareholders was -¥912,405,010.11, a significant decline from ¥9,346,950.67 in the previous year, representing a decrease of 9,861.53%[18]. - The net cash flow from operating activities was -¥458,226,892.00, compared to ¥45,616,436.03 in the same period last year, marking a decline of 1,104.52%[18]. - The company's total assets decreased to ¥9,886,339,569.09, down 10.41% from ¥11,034,911,100.95 at the end of the previous year[18]. - The net assets attributable to shareholders decreased to ¥7,128,935,853.59, a reduction of 10.27% from ¥7,945,095,398.41 at the end of the previous year[18]. - Basic earnings per share were -¥1.00, a decrease of 10,118.10% from ¥0.01 in the previous year[19]. - The weighted average return on net assets was -11.94%, a decrease of 12.10 percentage points from 0.16% in the same period last year[19]. Research and Development - Significant progress was made in product commercialization, clinical trials, and pipeline expansion during the reporting period[4]. - The company is committed to maintaining a substantial scale of R&D investment for ongoing clinical research and global clinical trials[4]. - Research and development expenses accounted for 112.28% of operating revenue, an increase of 67.48 percentage points compared to 44.80% in the same period last year[19]. - The company has developed a first-in-class PD-1 monoclonal antibody, Tretinoin, which has been approved for 5 indications in China, including treatment for metastatic melanoma and nasopharyngeal carcinoma[26]. - The company has a comprehensive R&D pipeline that includes small molecules, peptide drugs, antibody-drug conjugates, and next-generation therapies for cancer and autoimmune diseases[27]. - The company is focusing on innovative drug discovery and has developed multiple technology platforms for antibody screening and production[27]. - The company has established a global integrated R&D process with centers in San Francisco, Maryland, Shanghai, and Suzhou[27]. - The company has received IND approval for its first-in-human anti-BTLA monoclonal antibody, tifcemalimab, and is conducting multiple Ib/II clinical trials in China and the US[27]. Product Pipeline and Commercialization - The commercialized product, Toripalimab (JS001), is China's first domestically developed PD-1 monoclonal antibody, approved for over 15 indications and has conducted more than 30 clinical studies globally[35]. - The company’s product pipeline includes three commercialized products: Toripalimab, Etesevimab, and Adalimumab, with ongoing key registration clinical trials for several candidates[35]. - The company has established partnerships with international biotech firms to enhance its product pipeline, including collaborations for Toripalimab in the U.S. and Canada[34]. - The sales revenue of Toripalimab in the domestic market reached approximately 298 million yuan in the first half of 2022, with a 212% increase in Q1 2022 compared to Q4 2021, and a 70% increase in Q2 2022 compared to Q1 2022[36]. - Toripalimab has been included in the medical insurance directory for multiple indications, allowing for supplementary reimbursement in 113 provinces/cities, benefiting more patients[36]. - The company has achieved over 4,000 medical institution sales and nearly 2,000 pharmacy sales for Toripalimab, indicating strong market penetration[35]. Clinical Trials and Regulatory Approvals - The company has received FDA acceptance for the Biologics License Application (BLA) for Toripalimab, indicating progress towards market expansion in the U.S.[34]. - The company has received clinical trial approval for Tifcemalimab from both the FDA and NMPA, marking a significant milestone in its drug development[97]. - The company is conducting multiple ongoing clinical trials for VV116 (JT001) and other drugs, including a Phase III trial for a PCSK9 monoclonal antibody in broader patient populations[105]. - The company has received IND approvals for several monoclonal antibodies, including JS105 and JS107, which have received IND approvals in both China and the U.S.[87]. Financial Risks and Challenges - The company anticipates that high costs associated with new drug applications and market promotion may further increase short-term losses[4]. - The company has detailed various risk factors it may encounter in its production and operation processes[4]. - The financial risk associated with foreign currency fluctuations remains a concern, particularly with assets and liabilities denominated in currencies such as HKD, USD, EUR, CHF, and GBP[114]. - The company faces risks related to high R&D costs and potential delays in clinical trials due to the ongoing impact of the COVID-19 pandemic[117]. Environmental and Social Responsibility - The company has established a dedicated environmental health and safety department to manage pollutant discharge effectively[141]. - The company has implemented an environmental self-monitoring plan for 2022, with all monitored pollutants meeting discharge standards[144]. - The company has committed to environmental responsibility by adhering to pollution prevention measures and ensuring compliance with environmental regulations[148]. - The company actively adjusted its electricity consumption behavior to reduce carbon emissions, promoting green office practices and resource conservation among employees[148]. Shareholder and Corporate Governance - The company has a long-term commitment to a profit distribution policy, as detailed in the prospectus, ensuring transparency and adherence to investor protection measures[165]. - The company has confirmed that there are no significant legal violations or ongoing major litigation that could impact investor rights or public interest[165]. - The company is committed to maintaining transparency and integrity in its shareholding practices, especially during management transitions[156]. - The company has pledged to maintain independence in its operations, assets, and finances, ensuring no direct or indirect competition with its controlling shareholder or related entities[167].
君实生物(688180) - 2022 Q1 - 季度财报
2022-04-29 16:00
Financial Performance - The company's revenue for Q1 2022 was RMB 629,519,132.31, representing a decrease of 61.02% compared to the same period last year[4] - The net loss attributable to shareholders was RMB -396,395,486.59, a decline of 205.06% year-over-year[4] - The company reported a net profit excluding non-recurring items of RMB -429,583,325.21, a decline of 218.99% compared to the same period last year[4] - The net profit attributable to the parent company for Q1 2022 was -396,395,486.59 CNY, compared to a profit of 377,321,280.11 CNY in Q1 2021, indicating a significant decline[19] - The total comprehensive income for Q1 2022 was -471,770,135.33 CNY, compared to 379,422,645.53 CNY in Q1 2021, reflecting a substantial decrease[19] - The basic and diluted earnings per share for Q1 2022 were both -0.44 CNY, down from 0.43 CNY in Q1 2021[19] Cash Flow and Liquidity - The net cash flow from operating activities was RMB 570,432,127.10, an increase of 42.75% compared to the previous year[4] - Cash flow from operating activities for Q1 2022 was 570,432,127.10 CNY, a decrease from 399,613,641.51 CNY in Q1 2021[20] - Cash and cash equivalents increased to ¥4,259,927,063.42 in Q1 2022, up from ¥3,506,637,890.39 at the end of 2021, representing a growth of 21.5%[14] - The company’s cash and cash equivalents at the end of Q1 2022 stood at 4,258,353,489.75 CNY, up from 3,282,286,048.21 CNY at the end of Q1 2021[21] - The company received 380,000,000.00 CNY from minority shareholders in Q1 2022, marking a significant inflow compared to the previous year[20] - The cash outflow for investing activities in Q1 2022 was -175,320,677.30 CNY, an improvement from -489,544,165.73 CNY in Q1 2021[20] Research and Development - R&D expenses totaled RMB 510,912,040.65, accounting for 81.16% of revenue, which is an increase of 53.26 percentage points year-over-year[5] - R&D expenses increased to ¥510,912,040.65 in Q1 2022, up 13.3% from ¥450,649,443.76 in Q1 2021[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 10,953,222,268.79, a decrease of 0.74% from the end of the previous year[5] - Total assets as of March 31, 2022, were ¥10,953,222,268.79, slightly down from ¥11,034,911,100.95 at the end of 2021[17] - Total liabilities decreased to ¥2,651,629,271.81 in Q1 2022 from ¥2,718,536,814.27 in Q4 2021, a reduction of 2.5%[16] - The company reported a significant increase in long-term equity investments to ¥502,348,197.82 in Q1 2022, up from ¥457,791,434.27 in Q4 2021[16] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 33,735, with HKSCC NOMINEES LIMITED holding 24.08% of shares[9] - The number of A-share shareholders was 33,727 as of the report date[12] Sales Performance - The sales revenue from the product Tuoyi® (JS001) in Q1 2022 was RMB 110 million, showing significant growth compared to previous periods[5] - Operating costs for Q1 2022 were ¥1,012,253,166.19, down from ¥1,154,773,625.99 in Q1 2021, reflecting a reduction of 12.3%[18] Other Financial Metrics - The weighted average return on net assets was -5.10%, a decrease of 11.34 percentage points year-over-year[5] - The company experienced a significant decline in technology licensing income, which contributed to the overall revenue drop[7]
君实生物(01877) - 2022 Q1 - 季度财报
2022-04-29 13:24
Revenue and Profitability - The company's revenue for Q1 2022 was RMB 629,519,132.31, representing a decrease of 61.02% compared to the same period last year[5] - The net loss attributable to shareholders was RMB -396,395,486.59, a decline of 205.06% year-over-year[5] - The basic and diluted earnings per share were both -0.44 yuan, reflecting a decline of 202.33% year-over-year[5] - The net profit attributable to shareholders of the parent company for Q1 2022 was -396,395,486.59 CNY, compared to 377,321,280.11 CNY in Q1 2021, indicating a significant decline[19] - The total comprehensive income for Q1 2022 was -471,770,135.33 CNY, compared to 379,422,645.53 CNY in Q1 2021, reflecting a substantial decrease[19] Cash Flow - The net cash flow from operating activities was RMB 570,432,127.10, an increase of 42.75% compared to the previous year[5] - Cash flow from operating activities in Q1 2022 was 1,544,045,956.19 CNY, slightly down from 1,572,798,247.65 CNY in Q1 2021[20] - The net cash flow from operating activities for Q1 2022 was 570,432,127.10 CNY, compared to 399,613,641.51 CNY in Q1 2021, showing an improvement[20] - The net cash flow from investing activities for Q1 2022 was -175,320,677.30 CNY, compared to -489,544,165.73 CNY in Q1 2021, indicating reduced cash outflow[20] - The net cash flow from financing activities for Q1 2022 was 357,189,314.87 CNY, compared to -18,839,104.49 CNY in Q1 2021, showing a positive shift[20] - The cash and cash equivalents at the end of Q1 2022 amounted to 4,258,353,489.75 CNY, up from 3,282,286,048.21 CNY at the end of Q1 2021[21] - The company received 380,000,000.00 CNY from investments in Q1 2022, marking a significant inflow compared to the previous year[20] Research and Development - Research and development expenses totaled RMB 510,912,040.65, accounting for 81.16% of revenue, which is an increase of 53.26 percentage points year-over-year[6] - R&D expenses increased to ¥510,912,040.65 in Q1 2022, compared to ¥450,649,443.76 in Q1 2021, reflecting a growth of 13%[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 10,953,222,268.79, a slight decrease of 0.74% from the end of the previous year[6] - Total assets as of Q1 2022 were ¥10,953,222,268.79, slightly down from ¥11,034,911,100.95 at the end of the previous period[17] - Total liabilities amounted to ¥2,651,629,271.81 in Q1 2022, compared to ¥2,718,536,814.27 in the previous period[16] - The company reported a decrease in total equity to ¥8,301,592,996.98 from ¥8,316,374,286.68[16] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 33,735, with HKSCC NOMINEES LIMITED holding 24.08% of shares[10] Other Income - The company reported non-operating income of RMB 33,187,838.62, primarily from non-current asset disposal gains and government subsidies[7] - The company reported a decrease in other comprehensive income, with a net amount of -50,581,534.74 CNY for Q1 2022, compared to 2,101,658.95 CNY in Q1 2021[19] Inventory and Receivables - Accounts receivable decreased to ¥352,440,767.40 from ¥1,293,122,136.21, indicating a significant reduction of 73%[15] - Inventory increased to ¥509,224,927.05 from ¥484,601,367.48, showing a growth of 5%[15]
君实生物(01877) - 2021 - 年度财报
2022-04-29 08:30
Financial Performance - For the year ended December 31, 2021, the total revenue of the group reached RMB 4,025 million, an increase of 152% compared to 2020[9]. - Revenue for the year ended December 31, 2021, reached RMB 4,024.84 million, a significant increase from RMB 1,594.90 million in 2020, representing a growth of approximately 152.3%[27]. - Gross profit for the same period was RMB 2,766.65 million, up from RMB 1,222.37 million in 2020, indicating a growth of about 126.4%[27]. - The company reported a net loss from continuing operations of RMB 728.18 million for 2021, compared to a loss of RMB 1,665.64 million in 2020, showing an improvement of about 56.3%[27]. - The total comprehensive expenses for the year were RMB 718.58 million, a decrease from RMB 1,687.57 million in 2020, reflecting a reduction of approximately 57.4%[27]. - The total adjusted comprehensive expenses for the year ended December 31, 2021, amounted to RMB (485,888) thousand, a significant decrease from RMB (1,644,065) thousand in 2020, reflecting a reduction of approximately 70.5%[156]. - The company achieved sales revenue of RMB 412 million for the drug Tuoyi® in 2021, despite a price drop of over 60% compared to the initial pricing in 2020[20]. Research and Development - Research and development expenses totaled RMB 2,069 million, a 16% increase from 2020, primarily due to expanded R&D investments and team growth[9]. - The company has developed a range of innovative therapies across five major therapeutic areas, including malignant tumors and autoimmune diseases[10]. - The company has expanded its R&D capabilities to include small molecules, peptide drugs, and nucleic acid drugs, among others[10]. - The company has advanced over ten innovative drugs from preclinical development to clinical trial stages, including potential first-in-class candidates like IL-21 and CD112R (PVRIG)[37]. - The company is actively pursuing research and development projects across various disease areas, including oncology and autoimmune diseases[74]. - The company has established a pipeline of over 51 products across five major therapeutic areas, including monoclonal antibodies, small molecule drugs, antibody-drug conjugates (ADCs), bispecific fusion proteins, and cell therapies[37]. Clinical Trials and Approvals - Three products are in the commercialization stage, while 23 products are in clinical trials, including four in Phase III trials[10]. - The company has received IND approvals for several new products, including JS110 and JS111, which target specific mutations in cancer treatment[12]. - The company has initiated a Phase III clinical study (JUPITER-15) for Tuoyi® as an adjuvant treatment for gastric or gastroesophageal junction adenocarcinoma, with the first patient dosed in February 2022[25]. - The company is conducting an international multi-center, randomized, double-blind Phase III clinical study to evaluate the efficacy and safety of VV116 for moderate to severe COVID-19 patients[19]. - The company has initiated a Phase II/III clinical study for VV116 targeting mild to moderate COVID-19 patients, with the first patient dosed in Shanghai[19]. - Tuoyi® has been recognized with several designations from the FDA, including priority review and orphan drug status, enhancing its market competitiveness[50]. - The company has received approval for the drug Junmai Kang® (Adalimumab) for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis in March 2022[25]. Collaborations and Partnerships - The company signed an exclusive licensing and commercialization agreement with Coherus, potentially worth up to $1.11 billion, including a $150 million upfront payment[10]. - In January 2022, Coherus exercised an option to develop TAB006/JS006, resulting in a one-time payment of $35 million and potential milestone payments up to $255 million, plus an 18% sales share on net sales in Coherus' region[26]. - The company has entered into a partnership with Jiangsu Chia Tai Tianqing Pharmaceutical to develop a joint venture focused on mRNA technology for various diseases, with both parties holding 50% ownership[20]. - The company signed a strategic collaboration with Coherus for the development and commercialization of its proprietary drug, with potential total payments up to $1.11 billion, including a $150 million upfront payment[60]. Market and Sales Strategy - The company is focused on global expansion while maintaining a strong foundation in the Chinese market[10]. - The company is optimistic about achieving over 50% market share in newly diagnosed patients for the indications included in the national medical insurance catalog[21]. - The company aims to achieve over 50% market share in newly diagnosed patients for indications included in the National Medical Insurance Catalogue[82]. - The commercialization team experienced significant instability in 2021, affecting execution and market activity effectiveness[79]. Financial Position and Capital Management - The net cash inflow from financing activities was RMB 2,666 million, mainly from the successful placement of new H shares and capital increase from a subsidiary[9]. - The company completed a placement of 36,549,200 new H-shares at a price of HKD 70.18 per share, generating a net cash inflow of approximately RMB 2,105 million, intended for drug research and pipeline expansion[21]. - The company plans to issue up to 70 million A-shares to raise a total of no more than RMB 3.98 billion, aimed at supporting R&D and production facility expansion[69]. - The company has approximately RMB 3,505 million in cash and cash equivalents as of the end of the reporting period, providing strong support for R&D and clinical trial needs[69]. - The company has a secured loan of RMB 500 million with a fixed interest rate of 3.90%, maturing on July 28, 2028, to support ongoing clinical trials and the construction of the Wujiang production base[188]. Employee and Organizational Development - The workforce has expanded to 2,805 employees, with 896 in drug R&D, 846 in product commercialization, and 742 in production, emphasizing the importance of talent retention and development[65]. - The company has established a performance management system to differentiate high and low performers, fostering a positive cycle for organizational performance[65]. - The company granted 7,129,000 restricted shares to eligible employees under the 2020 A-share restricted stock incentive plan during the reporting period[200].
君实生物(01877) - 2021 - 中期财报
2021-09-30 08:39
Financial Performance - For the period ending June 30, 2021, the total revenue reached RMB 2,114 million, representing a 268% increase compared to the same period in 2020, primarily driven by growth in licensing income[12]. - The company reported a profit of RMB 11 million, a turnaround from a loss of RMB 598 million in the same period of 2020, attributed to a significant revenue increase from RMB 575 million to RMB 2,114 million[12]. - The company achieved a net profit of RMB 10,533 thousand for the six months ended June 30, 2021, a significant turnaround from a net loss of RMB 597,899 thousand in the same period of 2020, marking a 102% improvement[22]. - The adjusted total comprehensive income (expenses) for the period was RMB 97,527 thousand, compared to a loss of RMB 588,765 thousand in the same period of 2020[98]. - The company reported a basic loss per share of RMB 0.01 for the six months ended June 30, 2021, compared to a loss of RMB 0.76 for the same period in 2020[100]. - The company reported a total comprehensive loss of RMB 4,210 thousand for the period, a significant improvement from a loss of RMB 593,273 thousand in the previous year[196]. Research and Development - Research and development expenses totaled RMB 947 million, a 34% increase year-over-year, due to increased investment in independent R&D and expansion of the R&D pipeline[12]. - The company has expanded its innovative R&D to include small molecules, peptides, antibody-drug conjugates (ADCs), and nucleic acid drugs, covering five major therapeutic areas[13]. - The company’s innovative R&D has expanded from monoclonal antibodies to include small molecule drugs, peptide drugs, antibody-drug conjugates (ADCs), and nucleic acid drugs, covering five major therapeutic areas[42]. - The company has developed a robust pipeline of innovative drugs, including small molecules and antibody-drug conjugates, targeting cancer and autoimmune diseases[25]. - The R&D pipeline includes drugs targeting various diseases, including cancer, autoimmune diseases, and metabolic disorders, showcasing a diverse therapeutic focus[46]. - R&D expenses for the reporting period amounted to RMB 947 million, a 34% increase compared to the same period in 2020, driven by the expansion of the product pipeline and the acceleration of clinical projects[161]. Product Development and Commercialization - Two products are in the commercialization stage, while one product is in the new drug application stage, and 16 products are in clinical trials, with three in Phase III trials[13]. - The product Tuoyi® (Tremelimumab) received Fast Track Designation from the FDA for the treatment of mucosal melanoma and has been approved for a Phase III clinical trial[13]. - The company signed an exclusive licensing and commercialization agreement with Coherus BioSciences, Inc., granting Coherus exclusive rights for Tuoyi® (Tremelimumab) in the U.S. and Canada, with potential payments totaling up to $1.11 billion, including a $150 million upfront payment[15]. - The company received conditional approval from NMPA for Tuoyi® (Tremelimumab) in combination with chemotherapy for advanced or metastatic esophageal squamous cell carcinoma[18]. - The core product, Toripalimab (JS001), is the first domestically approved anti-PD-1 monoclonal antibody in China, with multiple indications for advanced melanoma and nasopharyngeal carcinoma[25]. - The company has accelerated clinical trials for Toripalimab across more than 30 studies covering over 15 indications in China and internationally, with significant progress in perioperative treatments for various cancers[31]. Financial Position and Cash Flow - Net cash generated from operating activities was RMB 48 million, mainly due to cash received from revenue growth[12]. - Net cash from financing activities amounted to RMB 2,028 million, primarily due to the successful placement of new H-shares, raising approximately RMB 2,106 million[12]. - As of the reporting period, the company had cash and cash equivalents of approximately RMB 4,269 million, providing strong support for R&D and production facility expansion[41]. - The company’s total assets increased by 25% to RMB 10,042,191 thousand as of June 30, 2021, compared to RMB 8,010,864 thousand at the end of 2020[23]. - The company’s non-current assets rose by 34% to RMB 4,442,796 thousand from RMB 3,312,147 thousand at the end of 2020[23]. - As of June 30, 2021, cash and bank balances increased to RMB 4,269 million from RMB 3,385 million as of December 31, 2020, primarily due to fundraising activities and revenue growth[97]. Market and Competitive Landscape - The company continues to explore innovative therapies and expand its product pipeline to enhance its competitive position in the domestic PD-1 market[29]. - The company is facing intense market competition in terms of market share, promotion, and distribution for its products, particularly in the anti-PD-1 segment[164]. - The company is actively expanding its product pipeline across multiple disease treatment areas and will maintain significant R&D investments for preclinical research and global clinical trials[161]. - The company faces risks related to long profit cycles in the biopharmaceutical industry, with profitability dependent on the progress of drug approvals and sales post-launch[161]. - The company is committed to strategic research to mitigate risks associated with new drug development, including regular evaluations of ongoing projects[164]. Shareholder and Equity Information - As of June 30, 2021, the company had a total of 910,756,700 issued shares, including 691,461,000 A shares and 219,295,700 H shares[141]. - Major shareholder 熊鳳祥 directly holds 41,060,000 A shares, representing 5.94% of the total share capital[153]. - The combined holdings of the concerted action parties amount to 155,310,736 A shares, which is 22.46% of the total share capital[153]. - The company’s equity structure shows a diverse range of stakeholders, including institutional investors and individual shareholders[152]. - The company has a significant presence in the H share market, with multiple controlled entities holding substantial stakes[157]. Regulatory and Compliance - The company has received NMPA approval for several products and has submitted BLA to the FDA, indicating progress in regulatory approvals[43]. - The company has adopted high standards of corporate governance, with a board consisting of five executive directors, four non-executive directors, and five independent non-executive directors[176]. - The company has confirmed compliance with the securities trading standards for directors and supervisors during the reporting period[177]. - The company plans to adapt its operations to regulatory changes to mitigate potential policy risks[166].