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君实生物(01877) - 2023 - 年度业绩
2024-03-28 13:00
Financial Performance - For the year ended December 31, 2023, the total revenue of the group was approximately RMB 1,503 million, an increase of about 3% compared to the same period in 2022, primarily due to an increase in pharmaceutical product revenue[2]. - The company reported revenue of RMB 1,502,550 thousand for the year ended December 31, 2023, an increase of 3.4% compared to RMB 1,453,493 thousand in 2022[77]. - Pharmaceutical sales revenue was approximately RMB 1,190 million, up about 58% year-on-year, driven by new indications for Tuoyi® and improved supply capacity for Junmaikang®[51]. - The gross profit for the year was RMB 835,260 thousand, down from RMB 927,211 thousand in the previous year, reflecting a decrease of approximately 9.9%[77]. - The net loss for the year was RMB 2,533,882 thousand, slightly improved from RMB 2,582,095 thousand in 2022[79]. - The company incurred a loss before tax of RMB 2,489,887 thousand, compared to a loss of RMB 2,675,202 thousand in the previous year, indicating an improvement of approximately 6.9%[77]. - The company reported a basic loss attributable to shareholders of RMB 2,281,624,000 for the year ended December 31, 2023, compared to RMB 2,386,067,000 for 2022, indicating a slight improvement in performance[98]. Research and Development - Research and development expenses totaled approximately RMB 1,937 million, a decrease of about 19% compared to the same period in 2022, mainly due to the group's control over R&D investments in several early-stage pipelines[2]. - The company has nearly 30 products in clinical trials and over 20 in preclinical development across five major therapeutic areas[16]. - The ongoing clinical research for JS005, a humanized anti-IL-17A monoclonal antibody, has entered Phase III registration trials targeting moderate to severe plaque psoriasis[12]. - The company is advancing multiple late-stage pipeline projects, including a Phase III clinical study for tifcemalimab in combination with Teriprizumab for various cancers[11]. - The company is focused on innovative drug development, expanding from monoclonal antibodies to include small molecules, peptides, and nucleic acid drugs[16]. Product Approvals and Market Expansion - In January 2023, the oral nucleoside analog for COVID-19 treatment received conditional approval from the NMPA for adult patients with mild to moderate COVID-19[3]. - In December 2023, Tuoyi® was approved for a new indication as a perioperative treatment for adult patients with resectable IIIA-IIIB non-small cell lung cancer, becoming the first and only approved therapy of its kind in China[4]. - Treliprimab has been approved for 7 indications in China and is the first domestically developed PD-1 monoclonal antibody approved by NMPA[6]. - The company plans to commercialize Treliprimab in over 50 countries, including partnerships with Hikma and Dr. Reddy's for market expansion in various regions[8]. - The company has entered into a shareholder agreement to acquire a 40% stake in Excellmab, enabling exclusive rights for Treliprimab commercialization in several Southeast Asian countries[6]. Financial Position and Cash Flow - Cash and cash equivalents decreased from approximately RMB 5,997 million to approximately RMB 3,778 million, primarily due to net cash outflows from operating activities of about RMB 2,015 million[55]. - The company reported a significant increase in accounts receivable, which rose to RMB 483,226,004.74 in 2023 from RMB 238,185,594.33 in 2022, reflecting a growth of approximately 102.5%[111]. - The total liabilities as of December 31, 2023, were RMB 4,022,256,399.35, compared to RMB 2,782,035,912.21 in the previous year, indicating an increase of approximately 44.6%[114]. - The net cash flow from operating activities for 2023 was -2,004,982,096.97 RMB, compared to -1,776,200,913.10 RMB in 2022, indicating a decline in operational cash flow[118]. Strategic Initiatives and Future Outlook - The company plans to enhance production capacity for large molecule drugs and explore new production processes to improve cost competitiveness[50]. - The company aims to expand its product pipeline through licensing and collaboration with leading global pharmaceutical companies[50]. - The company plans to focus on new product development and market expansion strategies in the upcoming fiscal year[121]. - The company is actively exploring new indications for Treliprimab and has received orphan drug designation from TGA for its use in treating nasopharyngeal carcinoma[5]. - The company is committed to maintaining substantial R&D investments for clinical trials and new drug preparations, which may lead to further short-term losses[66].
君实生物(01877) - 2023 Q3 - 季度业绩
2023-10-27 12:17
Financial Performance - The company's revenue for Q3 2023 was approximately ¥316.75 million, representing a year-on-year increase of 16.31%[4] - The net profit attributable to shareholders for Q3 2023 was approximately -¥409.41 million, with a year-to-date net profit of -¥1.41 billion, indicating a significant loss[4] - Basic and diluted earnings per share for Q3 2023 were both -¥0.42, compared to -¥1.43 in the same period last year[5] - Total operating revenue for the first three quarters of 2023 was RMB 986,457,567.67, a decrease of 19.06% compared to RMB 1,218,381,861.73 in the same period of 2022[16] - The net loss for the third quarter of 2023 was RMB 1,555,128,891.35, compared to a net loss of RMB 1,734,538,953.68 in the same quarter of 2022, indicating an improvement[19] - The total comprehensive loss for the third quarter of 2023 was RMB -1,605,861,657.78, compared to RMB -1,755,730,362.15 in the same quarter of 2022[19] Research and Development - Total R&D expenses for Q3 2023 amounted to approximately ¥322.03 million, a decrease of 43.89% year-on-year, and accounted for 101.66% of revenue, down 109.07 percentage points[5] - Research and development expenses for the first three quarters of 2023 amounted to RMB 1,270,626,649.07, a decrease of 22.36% compared to RMB 1,636,118,643.63 in 2022[16] - The company plans to continue focusing on research and development to enhance its product offerings and market position[16] - The company is advancing clinical trials for its first-in-human anti-tumor antibody, tifcemalimab, with approvals from both the FDA and the National Medical Products Administration[12] Assets and Liabilities - The total assets at the end of Q3 2023 were approximately ¥11.59 billion, a decrease of 7.73% compared to the end of the previous year[5] - The equity attributable to shareholders decreased by 14.96% year-on-year, amounting to approximately ¥8.06 billion[5] - Total liabilities as of the end of the third quarter of 2023 were RMB 3,249,445,547.44, an increase of 16.83% from RMB 2,782,035,912.21 at the end of 2022[18] - The total equity attributable to shareholders of the parent company decreased to RMB 8,064,611,883.59 from RMB 9,483,626,151.70 in the previous year, reflecting a decline of 14.93%[18] Cash Flow - The net cash flow from operating activities for the year-to-date was approximately -¥1.66 billion, indicating increased cash outflow compared to the previous period[7] - The net cash flow from operating activities for Q3 2023 was -1,664,114,192.65, compared to -1,117,489,221.19 in Q3 2022, indicating a decline in operational cash flow[21] - Total cash inflow from investment activities was 1,290,836,234.04, while cash outflow was 1,944,670,480.18, resulting in a net cash flow from investment activities of -653,834,246.14[21] - Cash inflow from financing activities amounted to 937,789,838.50, with cash outflow of 496,595,535.82, leading to a net cash flow from financing activities of 441,194,302.68[21] - The total cash inflow from operating activities was 1,236,480,347.79, while total cash outflow was 2,900,594,540.44, resulting in a significant operational cash deficit[21] Shareholder Information - The company reported a total of 32,991 common shareholders at the end of the reporting period[8] - The largest shareholder, HKSCC Nominees Limited, held 22.25% of the shares, totaling approximately 219.29 million shares[8] Product Sales and Market Strategy - The company achieved a commercial drug sales revenue of approximately RMB 892 million, representing a year-on-year growth of about 67.8%[12] - Sales revenue for the drug Toripalimab (brand name: Tuoyi®) reached approximately RMB 668 million, with a year-on-year increase of about 29.7%[12] - The company has not disclosed any new product developments or market expansion strategies in the current report[4] - The company plans to expand the commercialization of Toripalimab with more indications and ongoing clinical research for other products, which is expected to drive revenue growth[12] Inventory and Investments - The company’s inventory increased to approximately RMB 748 million from RMB 599 million at the end of 2022[14] - The company’s long-term equity investments decreased to approximately RMB 442 million from RMB 493 million at the end of 2022[14] - The company’s short-term borrowings were approximately RMB 340 million, slightly down from RMB 351 million at the end of 2022[14] - The company reported an increase in accounts receivable to approximately RMB 366 million, compared to RMB 238 million at the end of 2022[14] Cash and Cash Equivalents - The company’s cash and cash equivalents were approximately RMB 4.17 billion, down from RMB 6.03 billion at the end of 2022[14] - The ending balance of cash and cash equivalents as of Q3 2023 was 4,141,718,242.77, compared to 3,001,414,742.11 at the end of Q3 2022[22] - The total cash and cash equivalents at the beginning of the period were 5,996,935,997.83, indicating a strong liquidity position despite the net decrease in cash[22]
君实生物(01877) - 2023 - 中期财报
2023-09-28 08:30
上海君實生物醫藥科技股份有限公司 Shanghai Junshi Biosciences Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司) 股份代號: 1877 2023 中期報告 ...
君实生物(01877) - 2023 - 中期业绩
2023-08-30 12:10
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 截至2023年6月30日止六個月的 中期業績公告 上海君實生物醫藥科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈本公司及其附屬公司(「本集團」)截至2023年6月30日止六個月(「報告期」) 的未經審核簡明綜合中期業績及2022年同期的比較數字。本集團於報告期的未經 審核簡明綜合財務報表已由本公司審計委員會(「審計委員會」)及本公司核數師德 勤•關黃陳方會計師行審閱。除非另有說明,否則本公告的財務數據乃根據國際財 務報告準則(「國際財務報告準則」)編製。 於本公告中,「我們」指本公司,如文意另有所指,則指本集團。 財務摘要 ...
君实生物(01877) - 2023 Q1 - 季度业绩
2023-04-28 12:37
Financial Performance - The company's revenue for Q1 2023 was ¥255,154,522.24, representing a decrease of 59.47% compared to the same period last year[5] - The net profit attributable to shareholders for Q1 2023 was -¥543,432,303.73, indicating a significant loss[5] - The net cash flow from operating activities was -¥720,250,964.89, a decrease of 226.26% year-on-year[5] - Operating profit for Q1 2023 was -¥633,218,295.88, compared to -¥377,914,059.91 in Q1 2022[16] - Net loss attributable to shareholders for Q1 2023 was -¥543,432,303.73, compared to -¥396,395,486.59 in Q1 2022[17] - The company reported a total comprehensive loss of -¥667,067,229.83 for Q1 2023, compared to -¥471,770,135.33 in Q1 2022[17] - Basic and diluted earnings per share for Q1 2023 were both -¥0.55, compared to -¥0.44 in Q1 2022[17] Assets and Liabilities - Total assets at the end of Q1 2023 were ¥12,130,928,476.30, down 3.40% from the end of the previous year[6] - Total assets decreased to ¥12,130,928,476.30 in Q1 2023 from ¥12,558,496,175.43 in Q1 2022[15] - Total liabilities increased to ¥2,856,550,964.10 in Q1 2023 from ¥2,782,035,912.21 in Q1 2022[15] - The company’s total equity decreased to ¥9,274,377,512.20 in Q1 2023 from ¥9,776,460,263.22 in Q1 2022[15] - The equity attributable to shareholders decreased by 5.63% to ¥8,949,235,488.32 compared to the end of the previous year[6] Cash Flow - As of March 31, 2023, the company's cash and cash equivalents amounted to CNY 5.02 billion, a decrease from CNY 6.03 billion as of December 31, 2022[13] - The company’s cash and cash equivalents decreased by 1,012,308,195.11, compared to an increase of 753,748,651.03 in Q1 2022[20] - The ending balance of cash and cash equivalents was 4,984,627,802.72, down from 4,258,353,489.75 in the previous year[20] - In Q1 2023, the company reported a net cash flow from operating activities of -720,250,964.89, a significant decrease compared to 570,432,127.10 in Q1 2022[19] - Total cash inflow from operating activities was 302,002,091.08, down from 1,544,045,956.19 in the same period last year[19] - The company experienced a cash outflow from investing activities of 925,640,355.94, compared to 185,555,058.62 in Q1 2022, resulting in a net cash flow from investing activities of -492,872,825.63[19] - Cash inflow from financing activities was 248,567,750.19, down from 380,000,000.00 in Q1 2022, leading to a net cash flow from financing activities of 211,453,160.70[20] Research and Development - R&D investment totaled ¥527,659,904.54, which accounted for 206.80% of the revenue, an increase of 125.64 percentage points compared to the previous year[6][9] - Research and development expenses for Q1 2023 were ¥527,659,904.54, an increase from ¥510,912,040.65 in Q1 2022[16] Revenue Sources - The decrease in revenue was mainly due to a reduction in technology licensing income compared to the previous year, which had significant contributions from collaborations with Eli Lilly and Coherus BioSciences[8] - The revenue from the commercialized product, Toripalimab injection (brand name: Tuoyi®), reached approximately CNY 195.68 million, representing a year-on-year growth of about 77.84%[12] - The sales revenue of Adalimumab injection (brand name: Junmaikang®) was approximately CNY 29.07 million, while the sales revenue of Dexamethasone tablets (brand name: Mindewi®) was approximately CNY 11.50 million[12] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 36,266[10] Strategic Developments - The company has expanded its production capacity for Junmaikang® by adding a second production line at its subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd.[12] - The company has entered into a collaboration with Rxilient Biotech Pte. Ltd. for the development and commercialization of Toripalimab in nine countries in Southeast Asia[12] - The company anticipates continued rapid revenue growth driven by the approval of new indications for Toripalimab and the commercialization of other products in late-stage clinical development[12] - The company received conditional approval for Mindewi® and it has been temporarily included in the medical insurance payment scope[12]
君实生物(01877) - 2022 - 年度财报
2023-04-28 08:30
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 income from overseas licensing transfers[5]. - The loss attributable to owners of the company was RMB 2,386 million, an increase of RMB 1,667 million compared to 2021, primarily due to a decrease in licensing income[5]. - The net loss for 2022 was RMB 2,582.10 million, compared to a loss of RMB 728.18 million in 2021[16]. - The total revenue for 2022 was RMB 1,453.49 million, a decrease of 64.2% compared to RMB 4,024.84 million in 2021[16]. - Drug revenue amounted to approximately RMB 753 million, an increase of about 76% year-over-year, primarily due to enhanced commercialization capabilities and the approval of two new indications for Tuoyi®[78]. - Licensing revenue was approximately RMB 476 million, a decrease of about 86% year-over-year, mainly due to the completion of all milestone events in the agreement with Eli Lilly and Company in 2021[78]. - The basic loss per share for 2022 was RMB 2.60, consistent with the previous year's loss per share of RMB 0.80[18]. 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[5]. - The company has expanded its R&D from monoclonal antibodies to include small molecules, peptides, antibody-drug conjugates (ADCs), bispecific or multispecific antibodies, and nucleic acid drugs, covering five major therapeutic areas[7]. - The company has over 20 drugs in preclinical development, indicating a robust pipeline for future growth[7]. - The company has achieved multiple IND approvals for various drugs throughout 2022, reflecting its strong commitment to advancing its product pipeline[9]. - The company aims to establish a comprehensive R&D platform to capture opportunities in next-generation therapies, focusing on nucleic acid drugs, ADCs, and bispecific antibodies[23]. - The company is focused on developing innovative drugs and has a diverse pipeline including treatments for various cancers and metabolic diseases[38]. Product Development and Commercialization - The company achieved significant breakthroughs in innovative therapies and drug discovery, addressing unmet clinical needs and filling domestic gaps in several areas[6]. - As of the report date, the company has commercialized four drugs in China or overseas markets, with nearly 30 drugs in clinical trials, including three in Phase III trials[7]. - The core product Tuoyi® achieved a sales revenue growth of 78.77% year-on-year in the domestic market[22]. - Tuoyi® has been approved for six indications, with three included in the national medical insurance catalog, providing coverage in 137 cities for certain conditions[15]. - The company has submitted marketing applications for its product in the US, EU, and UK, which have been accepted by local regulatory authorities[22]. - The company has signed a collaboration agreement with Hikma for the exclusive development and commercialization of the drug Trelipril in 20 countries in the Middle East and North Africa, with potential payments up to $12 million[11]. Clinical Trials and Approvals - In May 2022, the company’s drug Mindev® demonstrated statistical superiority in a Phase III clinical study for early treatment of mild to moderate COVID-19, with a shorter median time to clinical recovery[8]. - The IND application for JS105 (a PI3K-α inhibitor) was approved by NMPA in May 2022, further enhancing the company's oncology pipeline[8]. - The IND application for JS116 (a KRASG12C small molecule inhibitor) was approved by NMPA in June 2022, showcasing ongoing innovation in targeted therapies[10]. - The company has successfully developed innovative drugs for COVID-19, including the oral antiviral drug Mindewi®, which was conditionally approved in China in January 2023[21]. - The company plans to submit sNDA for the two new indications to the NMPA in 2023[29]. - The company has multiple drugs in clinical trials, including JS007 targeting CTLA-4 and JS014 targeting IL-21, with several in Phase III and Phase II trials[39]. Financial Strategy and Funding - Net cash inflow from financing activities was RMB 4,643 million, mainly from the issuance of new A-shares on December 2, 2022, which generated a net cash inflow of RMB 3,748 million[5]. - In December 2022, the company raised RMB 3,776.50 million by issuing 70 million new A-shares at RMB 53.95 per share, funding innovative drug R&D and the Shanghai headquarters project[12]. - The company raised approximately RMB 4,836 million through the issuance of 87.13 million A-shares at a price of RMB 55.50 per share, with a net amount of RMB 4,497 million after deducting issuance costs[91]. - The company plans to utilize RMB 3,464 million for innovative drug research and development projects, expected to be fully utilized by December 31, 2026[98]. - The company has not declared or paid any dividends for the years ended December 31, 2022, and 2021[99]. Corporate Governance and Management - The company has implemented a corporate governance framework based on the corporate governance code, ensuring compliance with all applicable principles and provisions during the reporting period[149]. - The board consists of 14 members, including 7 executive directors, 2 non-executive directors, and 5 independent non-executive directors[152]. - The company has a commitment to high standards of corporate governance to protect shareholder interests and enhance corporate value[149]. - The management team emphasizes the importance of regulatory compliance and is actively working to ensure all new products meet the necessary standards[141]. - The company has established a shareholder communication policy to ensure effective responses to shareholder concerns and opinions[182]. Employee and Talent Development - The company emphasizes the importance of talent development and has implemented a performance management system to enhance employee capabilities and organizational performance[35]. - The company is committed to providing comprehensive employee benefits and improving the work environment to attract and retain talent[35]. - The company reported a significant increase in employee salaries and benefits by approximately 18% compared to the same period in 2021, despite overall reductions in sales and distribution expenses[80]. - The company has a total of 2,961 employees, with 995 in drug research and development, 989 in product commercialization, and 561 in production[35]. Market Expansion and Strategic Partnerships - The company is actively pursuing international clinical trials, indicating a strategy for global market expansion[36]. - The company is focused on innovation and aims to accelerate the clinical trial and market entry processes for new drugs, responding to industry and policy changes[126]. - The company has established partnerships with key industry players to enhance distribution networks, aiming for a 25% increase in market penetration[141]. - The company plans to acquire a 40% stake in Excellmab through a non-cash investment, enabling exclusive rights for developing and commercializing Trivapil monoclonal antibody in several Southeast Asian countries[14]. Risk Management - The company faces significant risks related to new drug development, including long R&D cycles, high investment, and low success rates, necessitating careful evaluation and potential discontinuation of underperforming projects[125]. - Financial risks include exposure to foreign exchange fluctuations, particularly with assets and liabilities denominated in HKD, USD, EUR, CHF, and GBP, which could impact operating performance[126]. - The company acknowledges operational risks related to the stability of supplier relationships and the potential impact of rising raw material costs on profitability[125]. - The company is aware of macroeconomic risks, particularly uncertainties in international trade relations, which could adversely affect overseas business operations[126].
君实生物(01877) - 2022 - 年度业绩
2023-03-30 13:37
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 截至2022年12月31日止年度的全年業績公告 上海君實生物醫藥科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈本公司及其附屬公司(「本集團」)截至2022年12月31日止年度(「報告期」) 的經審核綜合全年業績及截至2021年12月31日止年度的比較數字。本公司於報告 期的綜合財務報表已由本公司審計委員會(「審計委員會」)審閱,並由本公司核數 師審核。除非另有說明,否則本公告的財務數據乃根據國際財務報告準則編製。 於本公告,「我們」指本公司,如文意另有所指,則指本集團。 財務摘要 • 截至2022年12月31日,報告期內本集團收入總額約人民幣1,453百萬元,較 2021年同期下降約64%,主要由於本 ...
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].