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贝达药业(300558) - 2021 Q3 - 季度财报
2021-10-27 16:00
Financial Performance - The company's revenue for Q3 2021 was ¥569,266,996.07, representing a 2.42% increase year-over-year, while the year-to-date revenue reached ¥1,724,419,673.98, up 14.37% compared to the same period last year[5] - Net profit attributable to shareholders for Q3 2021 was ¥131,770,354.58, a decrease of 64.39% year-over-year, with a year-to-date net profit of ¥346,853,778.64, down 32.50% compared to the previous year[5] - The company reported a basic earnings per share of ¥0.32 for Q3 2021, down 65.22% year-over-year, and a diluted earnings per share of ¥0.31, down 65.93%[5] - Total operating revenue for the third quarter reached CNY 1,724,419,673.98, an increase of 14.4% compared to CNY 1,507,722,516.09 in the same period last year[27] - Net profit attributable to the parent company was CNY 346,853,778.64, down 32.5% from CNY 513,827,655.16 in the previous year[28] - Operating profit decreased to CNY 383,479,137.34, a decline of 37.4% compared to CNY 613,155,872.02 in the same quarter last year[27] - Total comprehensive income for the period was CNY 419,244,792.19, compared to CNY 504,864,053.52 in the same quarter last year[28] - Basic earnings per share decreased to CNY 0.84 from CNY 1.28 in the previous year[28] Research and Development - Research and development expenses for the first nine months of 2021 totaled ¥60,217,570, accounting for 34.92% of total revenue, reflecting a 37.02% increase year-over-year[7] - Research and development expenses increased to CNY 365,531,682.04, representing a 37.0% rise from CNY 266,779,354.07 in the prior year[27] - The company has received clinical trial approval for BPI-23314 tablets, indicating ongoing investment in new product development[25] Cash Flow and Assets - The company's cash flow from operating activities for the year-to-date period was ¥460,457,758.90, showing a decrease of 6.09% compared to the previous year[5] - Cash flow from operating activities generated CNY 460,457,758.90, slightly down from CNY 490,329,482.04 in the previous year[30] - Total assets at the end of Q3 2021 were ¥5,681,035,768.82, an increase of 8.63% from the end of the previous year[5] - The company's cash and cash equivalents decreased by 44.23% to ¥750,593,035.82 compared to the end of the previous year[8] - The company's cash and cash equivalents decreased to CNY 750,593,035.82 from CNY 1,345,944,580.99, a decline of about 44.2%[24] - Accounts receivable increased by 163.20% to ¥138,476,016.95, attributed to increased sales of new drugs[8] - Inventory levels rose to CNY 279,213,920.81, up from CNY 188,593,932.18, indicating an increase of around 48.0%[24] - Total liabilities reached CNY 1,158,889,108.06, compared to CNY 1,085,342,634.36 at the end of 2020, reflecting an increase of about 6.8%[26] - The company's equity attributable to shareholders increased to CNY 4,522,508,063.49 from CNY 4,140,781,110.43, representing a growth of approximately 9.2%[26] Shareholder Information - The total number of common shareholders at the end of the reporting period is 28,100, with the top 10 shareholders holding a combined 66.54% of shares[10] - Ningbo Kaiming Investment Management Partnership holds 19.28% of shares, amounting to 80,064,000 shares, and has pledged 37,810,000 shares[10] - Zhejiang Jihe Venture Capital holds 13.08% of shares, totaling 54,324,000 shares[10] - The total number of shares held by the top 10 shareholders is 277,000,000 shares[11] - The actual controller holds a total of 23.02% of shares through various investment partnerships[11] - The number of shares held by the top 10 shareholders participating in margin trading is 77,284,000 shares[11] Stock Options and Incentives - The company has implemented stock option incentive plans, with 231 participants exercising options at a price of 34.85 RMB per share, involving 2,142,190 options[15] - The total share capital increased from 41,498,520 shares to 41,530,510 shares due to the exercise of stock options[15] - The company has a total of 1,416,665 restricted shares at the end of the reporting period, with 12,750 shares released from restrictions[13] - The total number of restricted shares to be granted under the 2021 incentive plan has been adjusted from 15.55 million shares to 15.53 million shares, with the number of incentive recipients reduced from 468 to 466[19] - The initial grant of restricted shares has been adjusted from 12.7479 million shares to 12.7279 million shares, with a reserved portion of 2.8021 million shares, accounting for 18.04% of the total[19] - The cumulative number of stock options exercised and registered as of the report date is 2.14219 million shares, representing 96.25% of the total available options[16] Other Financial Information - The company reported a significant increase in other receivables by 472.12% to ¥38,955,380.86, mainly due to increased employee stock option tax receivables[8] - The company reported a net cash outflow from investing activities of CNY -899,198,899.41, compared to CNY -446,143,499.85 in the previous year[30] - The company’s financial statements for the third quarter of 2021 were unaudited[36]
贝达药业(300558) - 2021 Q2 - 季度财报
2021-08-09 16:00
Financial Performance - The company's operating revenue for the reporting period was ¥1,155,152,677.91, representing a 21.35% increase compared to ¥951,884,867.49 in the same period last year[13]. - Net profit attributable to shareholders was ¥215,083,424.06, a 49.57% increase from ¥143,798,418.73 year-over-year[13]. - The net profit after deducting non-recurring gains and losses was ¥197,517,963.56, up 39.85% from ¥141,238,347.17 in the previous year[13]. - The net cash flow from operating activities decreased by 35.25% to ¥228,977,955.65 from ¥353,608,692.17 in the same period last year[13]. - The total assets at the end of the reporting period were ¥5,596,696,415.37, reflecting a 7.02% increase from ¥5,229,537,607.09 at the end of the previous year[13]. - The net assets attributable to shareholders increased by 5.81% to ¥4,381,261,315.95 from ¥4,140,781,110.43 at the end of the previous year[13]. - Total revenue for the reporting period reached approximately 1.155 billion CNY, reflecting a year-on-year increase of 21.35%[50]. - The cost of sales increased by 24.38% year-on-year, amounting to approximately 84.29 million CNY[50]. - R&D expenses rose to approximately 398.38 million CNY, marking a 6.98% increase compared to the previous year[51]. - The gross margin for drug sales was reported at 94.06%, with a year-on-year increase in sales revenue of 22.79%[52]. Research and Development - R&D investment reached 398 million CNY, accounting for 34.49% of total revenue, supporting a robust pipeline of innovative drugs[28]. - The company has established a comprehensive drug development platform, integrating drug discovery, development, production, and commercialization[24]. - The company submitted 7 IND applications and 2 NDA applications during the reporting period, showcasing its commitment to advancing its drug development pipeline[28]. - The company is actively evaluating and adjusting its research projects based on progress and regulatory requirements, ensuring compliance with disclosure obligations[44]. - The company has multiple ongoing clinical trials for various drug candidates, including those targeting ERK1/2 and FGFR1/2/3, reflecting its strategic focus on innovative cancer therapies[43]. Market Position and Strategy - The company aims to address unmet medical needs in lung cancer treatment through its innovative drug development strategy[20]. - The company is focusing on lung cancer treatment, with a comprehensive strategy that includes various targeted therapies and combination treatments, aiming to meet the unmet clinical needs of lung cancer patients[45]. - The company plans to enhance its market positioning for its products and strengthen patient education initiatives[72]. - The company is actively adapting to changes in market access policies to ensure continuous medication availability for patients[30]. - The company has made significant progress in strategic collaborations, with multiple projects receiving clinical trial approvals, including MCLA-129 and BPI-D0316[32]. Environmental Compliance - The company reported a total wastewater discharge of 0.801 tons of COD, with a concentration of 36.4 mg/L, adhering to the Grade 3 discharge standard[89]. - The company achieved a total nitrogen discharge of 0.098 tons, with a concentration of 12 mg/L, compliant with the relevant discharge standards[89]. - The company has implemented a comprehensive pollution prevention facility at both sites, ensuring proper treatment of wastewater before discharge[92]. - The company has established a robust monitoring system for emissions, with all reported values within the regulatory limits[91]. - The company is classified as a key pollutant discharge unit by environmental protection authorities[88]. Share Capital and Stock Options - The total share capital increased from 413,162,913 shares at the beginning of the period to 414,985,201 shares at the end of the period[12]. - The second phase of the stock option incentive plan had 182.2288 thousand options exercised at a price of 34.85 yuan per option, increasing the total share capital from 413,162.9131 thousand shares to 414,985.2010 thousand shares[85]. - The company has been actively involved in stock option incentive plans, with the latest plan resulting in an increase of registered capital by CNY 182,228.80[164]. - The number of restricted shares decreased by 10,001,246, while unrestricted shares increased by 11,823,534, resulting from the lifting of restrictions on shares issued to specific investors[118]. - As of June 30, 2021, a total of 1,822,288 shares were exercised under the stock option incentive plan, including 280,500 shares by directors and senior management[117]. Corporate Governance - The company held its first extraordinary general meeting of shareholders on January 22, 2021, with a participation rate of 55.73%[80]. - The annual general meeting for 2020 took place on April 15, 2021, with a participation rate of 57.37%[80]. - The company has not reported any significant changes in the feasibility of the committed investment projects[65]. - The company has not engaged in any derivative investments during the reporting period[69]. - The company has not experienced any changes in its controlling shareholder or actual controller during the reporting period[135]. Financial Position - The total liabilities reached ¥1,214,785,525.54, up from ¥1,085,342,634.36, indicating an increase of approximately 11.9%[139]. - Shareholders' equity totaled ¥4,381,910,889.83, compared to ¥4,144,194,972.73, reflecting an increase of about 5.7%[140]. - The company reported a significant increase in other receivables, which rose to ¥672,978,782.76 from ¥543,387,489.27, a growth of approximately 23.8%[141]. - The company's total assets reached CNY 5,418,004,752.61 as of June 30, 2021, compared to CNY 5,103,856,075.89 at the end of 2020, reflecting a growth of 6.2%[144]. - The company's total equity attributable to shareholders at the end of the first half of 2021 was ¥4,381,910,889.83, compared to ¥4,144,194,972.73 at the end of the previous year[156].
贝达药业(300558) - 2021 Q1 - 季度财报
2021-04-28 16:00
Financial Performance - Total revenue for Q1 2021 was ¥618,561,581.32, a decrease of 4.41% compared to ¥647,078,509.17 in the same period last year[4] - Net profit attributable to shareholders was ¥147,745,673.33, an increase of 13.24% from ¥130,473,244.06 year-on-year[4] - Net profit excluding non-recurring gains and losses was ¥140,370,122.42, up 7.32% from ¥130,790,505.64 in the previous year[4] - Basic earnings per share increased to ¥0.36, a rise of 9.09% from ¥0.33 in the previous year[4] - The total comprehensive income for the first quarter was CNY 169,161,625.56, an increase from CNY 155,969,994.26 in the previous period, representing an increase of approximately 8.3%[44] - Net profit for Q1 2021 was ¥146.48 million, up 13.3% from ¥129.27 million in the same period last year[40] Cash Flow and Assets - Net cash flow from operating activities was ¥77,551,312.52, down 72.74% from ¥284,445,194.90 in the same period last year[4] - Cash inflow from operating activities totaled CNY 613,994,005.30, compared to CNY 607,333,461.77 in the previous period, showing a slight increase[45] - The net cash flow from operating activities was CNY 77,551,312.52, down from CNY 284,445,194.90 in the previous period, indicating a decrease of approximately 72.7%[46] - The ending cash and cash equivalents balance was CNY 830,780,852.07, up from CNY 674,110,141.01 in the previous period[47] - The company reported a net decrease in cash and cash equivalents of -CNY 515,163,728.92, compared to an increase of CNY 152,812,633.38 in the previous period[46] - Cash and cash equivalents decreased by 38.28% due to the transfer of bank wealth management products to other current assets[11] - The company has 830,780,852.07 in cash as of March 31, 2021, down from 1,345,944,580.99 on December 31, 2020[32] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 28,175[7] - The largest shareholder, Ningbo Kaiming Investment Management Partnership, held 19.38% of the shares[7] Research and Development - R&D expenses rose by 31.98% compared to the same period last year, reflecting ongoing investment in new drug development[11] - The company plans to continue focusing on R&D and market expansion strategies to drive future growth[39] - The company submitted IND applications for three candidate drugs (MCLA-129, BPI-421286, and Batilizumab injection) and one NDA application for BPI-D0316 during the reporting period[16] Strategic Initiatives - The company maintained a strong focus on its differentiated competitive strategy for its product, Kai Mei Na, which contributed to sales growth[12] - The company is focusing on risk management strategies to address market competition, new drug development, and potential loss of core technical personnel[18][20][22] - The company plans to strengthen its market positioning for Kaimena with a differentiated competition strategy and enhance patient education through new media[19] - The company has established strategic partnerships with over 10 domestic and international companies, enhancing its product pipeline through licensing and strategic investments[13] Financial Position - Total assets at the end of the reporting period were ¥5,348,236,146.44, an increase of 2.27% from ¥5,229,537,607.09 at the end of the previous year[4] - Net assets attributable to shareholders increased to ¥4,290,449,935.91, up 3.61% from ¥4,140,781,110.43 at the end of the previous year[4] - The total liabilities decreased to CNY 453,893,705.73 from CNY 489,989,827.62, representing a reduction of about 7.4%[38] - The company's equity increased to CNY 4,797,587,475.08 from CNY 4,613,866,248.27, indicating a growth of approximately 4.0%[38] Operational Efficiency - The company effectively controlled expenses, contributing to the increase in net profit attributable to shareholders[12] - Total operating costs decreased by 7.4% to ¥454.70 million from ¥491.08 million year-over-year[39] - Sales expenses decreased by 8.9% to ¥235.27 million from ¥258.31 million year-over-year[39] - The company experienced a tax expense reduction of 8.5%, down to ¥25.96 million from ¥28.41 million in the previous year[40]
贝达药业(300558) - 2020 Q4 - 年度财报
2021-03-25 16:00
Financial Performance - The company's operating revenue for 2020 was approximately ¥1.87 billion, representing a 20.36% increase from ¥1.55 billion in 2019[13]. - The net profit attributable to shareholders for 2020 was approximately ¥606.36 million, a significant increase of 162.70% compared to ¥230.82 million in 2019[13]. - The basic earnings per share for 2020 was ¥1.50, up 158.62% from ¥0.58 in 2019[13]. - The total assets at the end of 2020 reached approximately ¥5.23 billion, reflecting a 26.52% increase from ¥4.13 billion at the end of 2019[13]. - The total operating revenue for 2020 was 1,870,266,314.97 yuan, representing a year-on-year increase of 20.36% from 1,553,924,255.01 yuan in 2019[57]. - The company's drug sales reached 1,824,073,603.54 yuan, which is 97.53% of total revenue, with a year-on-year growth of 21.46%[57]. - The gross profit margin for drug sales was 94.04%, with a slight decrease of 0.74% compared to the previous year[58]. - The net profit attributable to shareholders, excluding non-recurring gains and losses, was 333.93 million yuan, reflecting a 60.30% increase compared to the previous year[26]. Product Development and Pipeline - The company is committed to developing targeted therapies for various cancers, including small cell lung cancer and non-small cell lung cancer[7]. - The company has a strong pipeline of products, including the innovative drug Ensartinib, which is a new generation ALK inhibitor[7]. - The company has established a rich and promising R&D pipeline, including five drugs in late-stage clinical research or submitted for market approval, alongside over twenty early-stage or preclinical candidates[41]. - The company has successfully partnered with several organizations, enhancing its pipeline with new drug candidates, including PD-1 and CTLA-4 antibodies, with multiple candidates already submitted for regulatory approval[43]. - The company plans to continue expanding its product offerings, with the second product, Beimeina, approved for market launch by the end of 2020[18]. - The company is currently in the process of clinical registration for multiple new drug applications, including "Bevacizumab Injection" and "Axitinib" for various cancer treatments[52]. - The company aims to solidify the market position of its drug, Kaimena, as the leading targeted therapy for lung cancer in China by enhancing clinical research and expanding commercial channels[93]. - The company will advance its pipeline products' clinical research and drug registration to ensure continuous growth and leverage the potential of sequential and combination therapies in oncology[95]. Research and Development - The company operates two R&D centers located in Beijing and Hangzhou, focusing on new drug development[6]. - The company’s R&D investment as a percentage of revenue has been substantial, with rates of 48.20%, 43.41%, and 39.69% over the past three years, indicating a strong commitment to innovation[41]. - In 2020, the company achieved a research and development investment of 742 million yuan, accounting for 39.69% of its operating revenue[47]. - The company is actively pursuing other preclinical research projects while adhering to disclosure obligations for significant project milestones[69]. Market Position and Competition - The company maintains a leading position in the first-generation EGFR-TKI market, leveraging clinical evidence and academic promotion to enhance brand recognition[27]. - The company faces intense market competition from similar drugs, necessitating a differentiated marketing strategy for Kaimena and Bemina[97]. - The successful launch of the drug Kaimena has disrupted the domestic EGFR mutation lung cancer targeted drug market, previously dominated by two major foreign pharmaceutical companies[141]. - The global and Chinese oncology drug market has shown significant growth, with a compound annual growth rate (CAGR) of 14.6% and 13.5% from 2015 to 2019 respectively[33]. Corporate Governance and Shareholder Relations - The company has engaged in multiple investor communications, including phone calls and on-site visits, to discuss performance and strategies[105]. - The company has committed to an active profit distribution policy following its initial public offering and listing on the Growth Enterprise Market[113]. - The company’s management has committed to accept supervision from regulatory authorities and the public regarding their commitments made during the IPO[119]. - The company has a clear governance structure with defined roles for its board members, ensuring effective oversight and management[184]. Environmental Compliance - The company has complied with all pollution discharge standards, with no instances of exceeding limits reported[145]. - The company has implemented pollution control measures in compliance with the "Comprehensive Emission Standards for Atmospheric Pollutants" and "Industrial Wastewater Nitrogen and Phosphorus Pollution Indirect Emission Limits" standards[148]. - The company has established a wastewater treatment facility with a capacity of 200 tons per day at both the Wuzhou Road and Xingzhong Road plants, ensuring compliance with municipal discharge standards[152]. Financial Management and Investments - The company raised a total of 1 billion yuan by issuing 10,138,621 shares to 14 institutional investors, aimed at funding new drug development and upgrading research equipment[52]. - The company has increased its equity assets by 155.83 million yuan, representing a growth of 131.25%, primarily due to the acquisition of a stake in Agenus during the reporting period[37]. - The company reported a total of 19,000 in entrusted financial management, with no overdue amounts[139]. - The company has not engaged in any repurchase transactions during the reporting period, indicating a focus on maintaining liquidity[181]. Social Responsibility - The company donated a total of 3 million RMB to support hospitals during the COVID-19 pandemic[143]. - The free medication program for Kaimena has benefited nearly 100,000 late-stage lung cancer patients, with a total of approximately 6 million boxes distributed[142]. Future Outlook - The company has projected a revenue growth of 20% for the next fiscal year, aiming for CNY 1.8 billion[195]. - New product launches are expected to contribute an additional CNY 200 million in revenue in the upcoming year[195]. - The management team emphasizes a commitment to sustainable practices, aiming for a 25% reduction in carbon footprint by 2025[195].
贝达药业(300558) - 2020 Q3 - 季度财报
2020-10-27 16:00
BETTA UXGIII 2020年第三季度报告 Quarterly Report 股票代码:300558 贝达药业股份有限公司 BETTA PHARMACEUTICALS CO., LTD. 贝达药业股份有限公司 2020 年第三季度报告全文 1 第一节 重要提示 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真 实、准确、完整,不存在虚假记载、误导性陈述或者重大遗漏,并承担个别和连 带的法律责任。 所有董事均已出席了审议本次季报的董事会会议。 公司负责人丁列明、主管会计工作负责人范建勋及会计机构负责人(会计主 管人员)王铁奇声明:保证季度报告中财务报表的真实、准确、完整。 贝达药业股份有限公司 2020 年第三季度报告全文 第二节 公司基本情况 一、主要会计数据和财务指标 | --- | --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------|----------------- ...
贝达药业(300558) - 2020 Q2 - 季度财报
2020-08-05 16:00
Financial Performance - The company reported a total revenue of RMB 1.2 billion for the first half of 2020, representing a year-on-year increase of 15%[4] - The net profit attributable to shareholders was RMB 300 million, an increase of 20% compared to the same period last year[4] - The company's operating revenue for the first half of 2020 was approximately ¥951.88 million, representing a 24.92% increase compared to the same period last year[11] - Net profit attributable to shareholders was approximately ¥143.80 million, a significant increase of 64.65% year-over-year[11] - The net profit after deducting non-recurring gains and losses reached approximately ¥141.24 million, marking an 87.90% increase compared to the previous year[11] - The net cash flow from operating activities was approximately ¥353.61 million, up 49.07% from the same period last year[11] - The company achieved a revenue of 952 million yuan, representing a year-on-year growth of 24.92%[26] - The net profit attributable to shareholders was 144 million yuan, with a year-on-year increase of 64.65%[26] - The total comprehensive income for the first half of 2020 was ¥156,129,952.17, compared to ¥85,848,109.17 in the first half of 2019, showing an increase of about 82%[134] - The company's total assets reached ¥4,070,052,102.52 as of June 30, 2020, compared to ¥3,845,603,045.09 at the end of 2019, indicating a growth of approximately 6%[131] Research and Development - The company has invested RMB 200 million in R&D for new drug development, which is 10% of its total revenue[4] - The company is advancing over 20 preclinical research projects, focusing on small molecule targeted drugs and expanding into large molecule drug development[50] - The company has over 30 ongoing research projects, with more than 10 products currently in clinical research, focusing on treatments for lung cancer and kidney cancer[36] - The company has established a leading new drug research and development system in China, supported by over 400 R&D personnel[36] - The company is actively pursuing market expansion and strategic partnerships, as evidenced by its investment in PD-1 and CTLA-4 projects[100] Product Development and Pipeline - The company plans to expand its product pipeline, focusing on new oncology drugs, with a target of launching at least two new products by the end of 2021[4] - The company has successfully completed Phase III clinical trials for its lead drug, which is expected to be submitted for regulatory approval by the end of 2020[4] - The company is advancing the registration of Ensartinib, a new ALK inhibitor, which has completed technical reviews and is undergoing site inspections for registration[21] - The company aims to submit a New Drug Application (NDA) for Alectinib by the end of 2020[47] - The company has two products currently in the registration process, with one undergoing on-site inspections and the other having its marketing application accepted by NMPA[44] Market Position and Strategy - The company is exploring potential mergers and acquisitions to enhance its market position and expand its product offerings[4] - The company has implemented a differentiated competitive strategy for Alectinib, which has been recognized by experts and patients, leading to increased sales[27] - Alectinib has been included in the national medical insurance and essential drug lists, facilitating its accessibility and driving sales growth[27] - The company has established a comprehensive sales model combining logistics distribution by distributors and academic promotion by the company[25] - The company plans to enhance its market positioning for Alectinib with a differentiated competition strategy and increase its market penetration[65] Social Responsibility and Community Engagement - The company donated a total of 3 million RMB to support hospitals in combating COVID-19, reflecting its commitment to social responsibility[40] - The company has provided over 5 million boxes of Alectinib for free to nearly 90,000 patients, significantly reducing their long-term medication burden[16] Financial Management and Investments - The company has no plans to distribute cash dividends for the current fiscal year, focusing instead on reinvestment into growth initiatives[4] - The company reported a government subsidy of approximately ¥9.18 million during the reporting period[15] - The company has not engaged in any entrusted financial management or derivative investments during the reporting period, reflecting a conservative financial strategy[60][61] - The company reported a net loss from investment activities of ¥268.30 million, an improvement of 33.05% compared to a loss of ¥400.72 million in the previous year[51] Environmental and Regulatory Compliance - The company operates two production facilities, with the Xizhong Road facility having detailed pollution prevention measures in place[94] - The Xizhong Road facility is a key pollutant discharge unit, adhering to the GB8978-1996 standard for wastewater discharge[93] - The company reported no instances of exceeding pollutant discharge standards during the reporting period[93][94] - The company has established an online monitoring system for daily monitoring of wastewater quality and quantity[98] Shareholder and Equity Information - The company’s total share capital increased from 401 million shares to 402.046429 million shares following the exercise of stock options[81] - The company’s independent directors approved adjustments to the stock option exercise prices and the cancellation of certain stock options during the board meetings held on May 22, 2020[80] - The company has not had any participants exercise their options as of the end of the reporting period for the first phase of the stock option incentive plan[80] - The largest shareholder, Ningbo Kaiming Investment Management Partnership, holds 19.91% of the shares, totaling 80,064,000 shares, with 24,178,000 shares pledged[110] Risk Factors - The company faces competitive risks in the market, particularly in the oncology segment, which may impact future performance[4] - The company is facing risks related to the loss of core technical personnel, which could impact project progress and market sales[68]
贝达药业(300558) - 2020 Q1 - 季度财报
2020-04-22 16:00
Financial Performance - Total revenue for the first quarter reached ¥647,078,509.17, an increase of 72.63% compared to ¥374,840,900.69 in the same period last year[6] - Net profit attributable to shareholders was ¥130,473,244.06, representing a growth of 152.36% from ¥51,701,709.01 year-on-year[6] - Net profit excluding non-recurring items was ¥130,790,505.64, up 172.23% from ¥48,043,663.61 in the previous year[6] - Basic earnings per share rose to ¥0.33, reflecting a 153.85% increase from ¥0.13 in the previous year[6] - The total comprehensive income for the period was CNY 131.36 million, up from CNY 47.25 million in the previous year, marking a 178.5% increase[36] Cash Flow and Assets - Net cash flow from operating activities was ¥284,445,194.90, a significant increase of 182.58% compared to ¥100,660,403.25 in the same period last year[6] - The company's cash and cash equivalents increased to CNY 674,110,141.01 from CNY 521,297,507.63, reflecting a growth of about 29.3%[26] - The total assets at the end of the reporting period were ¥4,489,646,472.87, an increase of 8.62% from ¥4,133,333,821.83 at the end of the previous year[6] - The total current assets reached ¥1,587,507,130.76 as of March 31, 2020, compared to ¥1,264,108,989.40 at the end of 2019, reflecting improved liquidity[30] - Cash and cash equivalents at the end of the period reached CNY 674,110,141.01, up from CNY 486,801,631.47, representing a 38.5% increase[42] Research and Development - Research and development expenses increased by 34.28% to ¥89.66 million, driven by investments in new drug development[12] - The company successfully submitted one IND application (BPI-28592) and advanced several clinical projects despite some delays due to the pandemic[17] - The company reported significant advancements in clinical trials, including the acceptance of applications for new drugs BPI-43487 and BPI-28592[21] - Research and development expenses rose to CNY 80.27 million, compared to CNY 59.72 million in Q1 2019, indicating a 34.4% increase[37] Market Strategy and Competition - Alectinib was included in the national medical insurance directory, enhancing its market accessibility and driving sales growth[14] - The company implemented a differentiated competition strategy for Alectinib, emphasizing its unique benefits over competitors[14] - The company faces significant market competition risks due to the implementation of the "4+7" volume-based procurement policy, which has led to substantial price reductions for its EGFR-TKI drug, Alectinib[19] - The company plans to enhance the market positioning of Alectinib with a differentiated competition strategy and aims to ensure dual-channel reimbursement through hospitals and designated pharmacies[19] Shareholder Information - The total number of shareholders at the end of the reporting period was 22,430, with the top ten shareholders holding significant stakes[9] - The company has not engaged in any repurchase transactions during the reporting period[10] Liabilities and Financial Obligations - The total liabilities of the company were CNY 1,868,946,411.44, up from CNY 1,664,118,718.42, indicating an increase of approximately 12.3%[28] - The company's long-term borrowings remained stable at CNY 280,000,000.00, unchanged from the previous period[28] - The company reported a significant increase in employee compensation liabilities, which rose to CNY 105,038,007.49 from CNY 93,024,217.49, an increase of approximately 12.9%[28] Operational Efficiency - The company maintained orderly operations during the COVID-19 pandemic, ensuring continuous supply of medications to patients[18] - The company is addressing the risk of core technical personnel turnover by implementing innovative compensation and incentive mechanisms[19] - The company is likely to continue its market expansion and product development strategies, as indicated by the increase in R&D spending and total assets[34]
贝达药业(300558) - 2019 Q4 - 年度财报
2020-04-20 16:00
Financial Performance - The company's revenue for 2019 was CNY 1,553,924,255.01, representing a 26.94% increase compared to CNY 1,224,171,768.53 in 2018[16]. - The net profit attributable to shareholders for 2019 was CNY 230,821,620.91, a 38.37% increase from CNY 166,818,363.66 in 2018[16]. - The net cash flow from operating activities reached CNY 555,074,095.21, showing a significant increase of 93.81% compared to CNY 286,396,896.75 in 2018[16]. - The total assets at the end of 2019 amounted to CNY 4,133,333,821.83, a 19.46% increase from CNY 3,460,085,536.96 at the end of 2018[16]. - The company reported a basic earnings per share of CNY 0.58 for 2019, up 38.10% from CNY 0.42 in 2018[16]. - The company achieved a weighted average return on equity of 9.84% in 2019, compared to 7.90% in 2018[16]. - The net profit after deducting non-recurring gains and losses was CNY 208,316,647.75, a 50.13% increase from CNY 138,755,929.59 in 2018[16]. - The company achieved operating revenue of 1.5539 billion yuan, a growth of 26.94% compared to the previous year, with a net profit attributable to shareholders of 230.82 million yuan, up 38.37% year-on-year[33]. Dividend Distribution - The company reported a profit distribution plan based on 401,000,000 shares, proposing a cash dividend of 1.9 yuan per 10 shares (including tax) and no bonus shares[5]. - The total distributable profit for the year was 1,510,998,377.88 yuan, with the cash dividend amounting to 76,190,000 yuan, accounting for 100% of the profit distribution[109]. - The company has maintained its cash dividend policy, ensuring that at least 20% of the distributable profit is allocated for cash dividends when the net profit is positive[106]. - The company has consistently increased its cash dividends over the past three years, with the amounts being 60,150,000 yuan in 2017, 44,110,000 yuan in 2018, and 76,190,000 yuan in 2019[110]. Research and Development - The company focuses on innovative drug research and development, particularly in the field of lung cancer treatment[21]. - The company has over 30 ongoing research projects, with 12 products currently in clinical research, focusing on the treatment of malignant tumors such as lung and kidney cancers[49]. - The company’s R&D investment in 2019 amounted to 675 million CNY, accounting for 43.41% of total revenue, which is a 14.33% increase year-on-year[55]. - The company is actively pursuing strategic collaborations to build a product matrix for precision cancer treatment, particularly in lung cancer therapies[50]. - The company is committed to increasing R&D investment to ensure the advancement of early clinical projects and the development of candidate compounds[96]. Market Position and Competition - The company emphasizes the importance of risk awareness regarding market competition and new drug development in its future outlook[5]. - The company faces significant market competition, particularly from generics in the EGFR-TKI category, which may impact Alectinib's market share[98]. - The company is implementing a differentiated competition strategy to maintain Alectinib's market position and ensure dual-channel reimbursement access[99]. - The domestic cancer market reached a sales figure of 102.437 billion yuan in 2019, with a year-on-year growth of 22.09%, and targeted drugs grew at a rate of 77.21%[41]. Corporate Governance and Compliance - The company has established a complete internal audit system, with the audit committee primarily composed of independent directors, ensuring effective oversight of financial reporting and internal controls[192]. - The company has implemented strict information disclosure practices, ensuring transparency and compliance with relevant regulations[191]. - The company has a clear governance structure with defined roles for the board, supervisory board, and management, enhancing operational efficiency[187]. - The company has maintained compliance with the relevant regulations of the China Securities Regulatory Commission and the Shenzhen Stock Exchange regarding shareholding reduction[115]. Environmental Responsibility - The company is classified as a key pollutant discharge unit by environmental protection authorities, with specific emissions monitored[139]. - The wastewater discharge standards are in compliance with the "Comprehensive Wastewater Discharge Standards" (GB8978-1996) at level three[139]. - The company has maintained zero exceedance in pollutant discharge limits across various monitored parameters[139]. - The company has established a wastewater treatment facility that operates normally without any exceedance of discharge limits[142]. Strategic Initiatives - The company is actively pursuing market expansion strategies, targeting entry into three new international markets by the end of 2020[171]. - A strategic acquisition of a smaller biotech firm was completed, enhancing the company's R&D capabilities and expected to generate synergies worth 100 million RMB annually[171]. - The company plans to increase its marketing budget by 15% to enhance brand visibility and support new product launches[171]. - The company aims to improve operational efficiency, targeting a reduction in costs by 5% through process optimization[174]. Shareholder Commitments - The company has committed to not transferring or entrusting the management of its shares for 36 months from the date of the stock issuance, which will end on November 6, 2019[112]. - The controlling shareholder, YINXIANG WANG, has pledged to limit cumulative share reductions to no more than 30% of the total shares held before the issuance within two years after the lock-up period[112]. - The company has established measures to avoid competition with its controlling shareholders and their affiliates[115]. - The company has successfully fulfilled its commitments regarding shareholding reduction and dividend distribution as of the reporting date[115].
贝达药业(300558) - 2019 Q3 - 季度财报
2019-10-24 16:00
Financial Performance - Operating revenue for the quarter reached CNY 481,454,889.06, a year-on-year increase of 39.05%[8] - Net profit attributable to shareholders increased by 37.15% to CNY 111,206,793.14 for the quarter[8] - The net profit after deducting non-recurring gains and losses rose by 60.88% to CNY 105,929,812.46[8] - The company’s basic earnings per share for the quarter was CNY 0.28, reflecting a 40.00% increase[8] - The company's total revenue for Q3 2019 reached ¥1,243,443,143.64, an increase from ¥927,590,528.05 in the same period last year, representing a growth of approximately 34%[44] - Net profit for Q3 2019 was ¥109,913,088.27, compared to ¥81,743,710.70 in Q3 2018, reflecting a year-over-year increase of about 34%[38] - The company reported a total profit of CNY 231,433,288.67 for Q3 2019, compared to CNY 176,731,279.49 in the same period last year, which is a growth of 30.9%[46] Asset and Liability Management - Total assets increased by 15.74% to CNY 4,004,626,572.19 compared to the end of the previous year[8] - Cash and cash equivalents increased by 70.66% to ¥520,453,992.03 due to higher product sales cash inflow and investment funds received from Guoxin Guotong[19] - Accounts receivable rose by 53.43% to ¥97,908,961.21, reflecting increased product sales during the reporting period[19] - Total liabilities as of September 30, 2019, were ¥935,405,270.49, compared to ¥914,597,429.06 in the previous year, showing a slight increase[35] - Owner's equity totaled CNY 2,201,712,151.95, including CNY 1,004,230,957.38 in undistributed profits[64] - Total liabilities reached approximately CNY 914.6 million, with current liabilities at about CNY 595.2 million[69] Research and Development - Research and development expenses rose by 31.58% to ¥244,700,320.91, reflecting increased investment in R&D projects[19] - Research and development expenses for Q3 2019 amounted to ¥83,606,874.51, compared to ¥67,986,988.19 in the previous year, indicating a growth of approximately 23%[37] - Research and development expenses increased to CNY 217,885,504.76, compared to CNY 161,815,069.34 in the previous year, marking a rise of 34.6%[50] Cash Flow Analysis - The net cash flow from operating activities for the year-to-date period was CNY 388,991,654.39, up 71.06%[8] - Operating cash inflow for Q3 2019 was CNY 1,240,208,599.08, an increase from CNY 1,063,137,873.01 in the previous year, representing a growth of approximately 16.7%[58] - Net cash flow from operating activities was CNY 404,573,429.33, up from CNY 291,476,577.01, indicating a year-over-year increase of about 38.8%[58] - Cash outflow from investing activities totaled CNY 276,861,166.66, compared to CNY 406,507,164.97 in the prior year, reflecting a decrease of approximately 31.9%[58] Market and Product Development - The sales volume of the product Alectinib increased by 33.15% year-on-year, contributing to the overall revenue growth[18] - The inclusion of Alectinib in the national medical insurance drug list positively impacted its sales growth[18] - The company plans to expand its market presence and enhance product offerings through ongoing R&D and strategic investments[22] - The company plans to continue expanding its market presence and investing in new technologies and products to drive future growth[37] Financial Ratios and Metrics - The weighted average return on net assets was 4.83%, an increase of 1.00% compared to the previous year[8] - The total liabilities to equity ratio as of September 30, 2019, was approximately 0.35, indicating a stable financial structure[35] - The company reported a significant asset impairment loss of 5495.54% due to provisions for the investment in Tyrogenex[19] Inventory and Other Assets - The company reported a total of CNY 144,993,645.00 in inventory, indicating potential for future sales growth[67] - The company has a total of CNY 723,203,481.48 in other receivables, indicating strong liquidity[67]