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德源药业(832735) - 2022 Q4 - 年度业绩预告
2023-02-06 16:00
Financial Performance - The estimated net profit attributable to shareholders for 2022 is projected to be between 11,000 and 12,500 thousand yuan, representing an increase of 41.22% to 60.48% compared to the previous year's net profit of 7,789.07 thousand yuan [3]. - The growth in net profit is primarily driven by the steady increase in sales volume of existing products and the launch of new products such as Ipatasertib tablets and Acarbose tablets, which have contributed to sustainable growth in operating performance [5]. - Significant sales growth was observed in the promoted compound products "Furuitong" and "Bokaiqing," leading to an increase in the number of patients served and an optimization of the product structure, enhancing the overall gross profit margin [5]. Management and Operations - The company has strengthened internal management, optimized personnel structure, and strictly controlled expenses, resulting in improved profitability [5]. - The financial data presented is preliminary and has not been audited, and the final figures will be disclosed in the official 2022 annual report [6].
德源药业(832735) - 关于卡格列净片(0.1g)获国家药监局签发药品注册证书的公告
2023-01-11 16:00
证券代码:832735 证券简称:德源药业 公告编号:2023-001 江苏德源药业股份有限公司 关于卡格列净片(0.1g)获国家药监局 江苏德源药业股份有限公司(以下简称"公司")于 2023 年 1 月 11 日取得国 家药品监督管理局签发的按照化学药品 4 类申报的卡格列净片(规格:0.1g)的 药品注册证书,且视同通过一致性评价。现将相关信息公告如下: 一、药品基本情况 规格:0.1g 注册分类:化学药品 4 类 批准文号:国药准字 H20233014 签发药品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记载、 误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连 带法律责任。 二、对公司的影响及风险提示 本次获得卡格列净片的药品注册证书,进一步丰富了公司在糖尿病领域的产 品管线,并与现有糖尿病领域产品形成协同效应、巩固并提升公司在糖尿病领域 的品牌效应和市场竞争力。 药品获得注册证书后,该产品由于受到市场环境和国家政策等因素的影响, 生产和销售情况会存在一定不确定性。敬请广大投资者谨慎决策,注意防范投资 风险。 从而降低血糖。该类靶点药物与其他降糖 ...
德源药业(832735) - 2022 Q3 - 季度财报
2022-10-25 16:00
Financial Performance - Operating revenue for the first nine months of 2022 was ¥470,360,144.98, representing a growth of 24.74% from ¥377,071,819.12 in the same period of 2021[16] - Net profit attributable to shareholders for the first nine months of 2022 was ¥70,171,109.16, up 26.68% from ¥55,393,002.13 year-on-year[16] - The gross profit margin for the same period was 79.85%, an increase of 2.03 percentage points year-on-year[23] - Total revenue for Q3 2022 reached ¥160,480,076.60, a 24.5% increase compared to ¥128,953,278.59 in Q3 2021[108] - Operating profit for Q3 2022 was ¥23,792,641.80, compared to ¥17,349,376.68 in Q3 2021, indicating a growth of 37.1%[109] - The company's net profit for Q3 2022 was approximately ¥19.43 million, a 33.5% increase from ¥14.62 million in Q3 2021[110] - The company reported a total profit of ¥19.05 million for Q3 2022, up from ¥15.96 million in Q3 2021, indicating a growth of 13.1%[114] Cash Flow - The net cash flow from operating activities for the first nine months of 2022 was ¥107,662,146.09, reflecting a 37.28% increase compared to ¥78,424,504.28 in the previous year[16] - Total cash inflow from operating activities reached CNY 475,179,838.70, up from CNY 373,096,524.00, reflecting a growth of 27.4% year-over-year[116] - Cash outflow for operating activities was CNY 367,517,692.61, compared to CNY 294,672,019.72 in 2021, representing an increase of 24.7%[116] - Financing activities resulted in a net cash outflow of CNY 21,879,398.28, a significant decrease from a net inflow of CNY 297,341,775.02 in 2021[118] Assets and Liabilities - Total assets as of September 30, 2022, reached ¥941,467,534.42, an increase of 12.34% compared to ¥838,022,957.26 at the end of 2021[15] - Total liabilities increased to ¥175,843,084.10 from ¥146,568,023.42, marking a rise of around 19.9%[102] - The equity attributable to shareholders rose to ¥765,624,450.32, up from ¥691,454,933.84, which is an increase of about 10.7%[102] - The company's accounts receivable at the end of the reporting period amounted to ¥110,485,900, a 16.39% increase, with a receivables turnover rate of 4.34, up from 4.06 in the previous year[18] Investments and R&D - Research and development expenses for the period were 50.81 million yuan, a year-on-year increase of 29.50%[24] - The company's long-term equity investments reached ¥9,703,100, primarily due to a capital increase of ¥10,000,000 to Beijing Jingda Biotechnology Co., Ltd.[19] - The company approved an investment of ¥8,000,000 in financial products and ¥80,000,000 in bank principal-protected products to enhance fund utilization efficiency[41] Shareholder Information - The largest shareholder, Li Yong'an, holds 6,761,216 shares, accounting for 10.36% of total shares[32] - The second-largest shareholder, the State-owned Research Institute, holds 6,300,000 shares, representing 9.66% of total shares[32] - The total number of unrestricted shares increased from 43,878,944 to 44,895,944, representing a rise from 67.25% to 68.81% of total shares[32] Commitments and Compliance - The company has ongoing commitments regarding environmental assessment procedures for certain products that did not obtain the necessary approvals between 2013 and 2014[51] - The company has committed to stabilizing its stock price as outlined in the stock issuance prospectus, with commitments valid until February 2024[51] - The company will publicly explain any failure to implement the promised measures to stabilize share prices and apologize to shareholders and the public investors[63] Market Outlook and Strategy - The company emphasizes strengthening R&D investment and market expansion to enhance its competitive and sustainable profitability, focusing on endocrine therapy drug development and sales[64] - The company aims to improve management efficiency and profitability by optimizing production processes and enhancing information management across procurement, production, inventory, and sales[65] - The company plans to review its shareholder dividend return plan at least every three years after listing on the selected tier, considering the opinions of shareholders and independent directors[71]
德源药业(832735) - 2022 Q2 - 季度财报
2022-08-18 16:00
Regulatory Approvals and Product Development - The company received a drug registration certificate for Acarbose tablets (50mg) from the National Medical Products Administration (NMPA) on January 30, 2022, which is considered equivalent to passing the consistency evaluation[4]. - Acarbose is effective in delaying carbohydrate absorption, significantly reducing postprandial blood sugar levels, and is widely used in China, where over 60% of type 2 diabetes patients are overweight or obese[5]. - The company and its wholly-owned subsidiary, Nanjing Deyuan, were granted a patent for a method to rapidly separate the racemic mixture of Pioglitazone hydrochloride using supercritical fluid chromatography on April 26, 2022[6]. - The company must complete consistency evaluations for its products, including Mecobalamin capsules and Candesartan tablets, within three years to maintain market competitiveness[15]. - The company has successfully passed the consistency evaluation for its products Metformin Hydrochloride Sustained-Release Tablets (0.5g), Nateglinide Tablets (0.12g), Pioglitazone Tablets (30mg), and Pioglitazone Metformin Tablets (15mg/500mg), showcasing its R&D capabilities[107]. - The company’s product Candesartan Cilexetil Tablets (Bokaiqing) was accepted for consistency evaluation in December 2021, with steady progress reported as of June 2022[107]. - The company decided not to pursue the consistency evaluation for Mecobalamin Capsules due to considerations of R&D costs and the complexity of BE trials, opting instead for an alternative product, Mecobalamin Tablets[108]. Financial Performance - The company's operating revenue for the current period reached ¥309,880,068.38, representing a year-on-year increase of 24.89% compared to ¥248,118,540.53 in the same period last year[29]. - The net profit attributable to shareholders of the listed company was ¥50,739,206.17, up 24.45% from ¥40,771,153.63 in the previous year[29]. - The gross profit margin improved to 80.96%, compared to 78.10% in the previous year[29]. - Total assets increased by 6.31% to ¥890,881,323.39 from ¥838,022,957.26 at the end of the previous year[30]. - The total liabilities rose by 7.79% to ¥157,989,440.13 from ¥146,568,023.42 at the end of the previous year[30]. - The net cash flow from operating activities was ¥55,806,540.82, reflecting a 7.56% increase from ¥51,885,938.84 in the previous year[31]. - The weighted average return on net assets based on net profit attributable to shareholders was 7.09%, down from 7.66% in the previous year[29]. - The company’s basic earnings per share increased to 0.80, an 11.11% rise from 0.72 in the previous year[29]. - The company achieved a sales revenue of 30,988.01 million yuan in the first half of 2022, representing a year-on-year growth of 24.89%[40]. - Operating profit for the same period was 6,327.12 million yuan, up 26.83% year-on-year, while net profit reached 5,073.92 million yuan, an increase of 24.45%[40]. Research and Development - The company invested 3,212.89 million yuan in R&D during the first half of 2022, accounting for 11.79% of total sales revenue[41]. - The company has received a total of 20 authorized patents, including 15 invention patents, enhancing its R&D capabilities[40]. - The company is focusing on drug research and development in the fields of geriatric and chronic diseases to enrich its product portfolio[99]. - The company has established a new product research and development project review system to reduce decision-making risks[99]. - The company is currently undergoing technical reviews for several new products, including Canagliflozin tablets and Phosphate Sitagliptin tablets[42]. Market Competition and Risks - Increased competition in the diabetes medication sector is expected, driven by rising diabetes prevalence and ongoing healthcare reforms, which may pressure the company's market share and profit margins[13]. - The pharmaceutical industry faces significant product development risks due to high investment, long cycles, and the potential for technical errors during research and development[13]. - The company is facing risks related to the shortage of high-level talent, which may impact future production and operations[14]. - Fluctuations in the prices of raw materials, such as Metformin and Candesartan, could affect profitability due to external procurement dependencies[14]. - The company is facing risks related to the supply of raw materials, with measures in place to diversify suppliers and establish long-term partnerships[104]. Talent Management - The company emphasizes the importance of attracting and retaining high-level technical and management talent to support its growth and product development initiatives[13]. - The company is actively working to attract and retain high-level talent through training and incentive mechanisms[102]. - The company has implemented a restricted stock incentive plan to motivate key employees and align their interests with the company's growth[103]. Social Responsibility and Environmental Compliance - The company has implemented a comprehensive wastewater treatment process that ensures treated water meets discharge standards[89]. - The company has established an online monitoring system for wastewater discharge that is connected to the local environmental authority[89]. - The company has maintained zero safety incidents during the reporting period[85]. - The company emphasizes the importance of social responsibility, aligning its business activities with community welfare initiatives[85]. - The company has developed an emergency response plan for environmental incidents and conducts regular training for employees[86]. Shareholder Commitments and Corporate Governance - The company has committed to fulfilling its obligations related to stock issuance and shareholder communications[127]. - The company has outlined its commitments to shareholders regarding stock price stabilization and compliance with regulatory requirements[126]. - The company will ensure that all commitments made in the public offering documents are being actively pursued and fulfilled[127]. - The company commits to strictly adhere to the lock-up period requirements as per the signed commitments and relevant laws and regulations, ensuring no reduction in shareholdings during this period[149]. - The company will compensate public investors for direct losses incurred due to reliance on commitments, with compensation amounts determined through negotiation or regulatory recognition[158]. Financial Management and Fund Utilization - The company has not engaged in any violations regarding the use of raised funds, ensuring compliance with regulations[182]. - The company has changed the use of part of the raised funds, with CNY 180,000,000 allocated to different purposes[180]. - The company has a significant number of shares pledged, with 18,204,162 shares under pledge among the major shareholders[176]. - The company has raised a total of CNY 308,666,100 through public stock issuance, with a net amount of CNY 284,194,253.77 after deducting issuance costs[181]. - The company has completed the use of 5,419.43 million of the excess fundraising to supplement working capital as of June 30, 2022[185].
德源药业(832735) - 2022 Q1 - 季度财报
2022-04-26 16:00
Financial Performance - Operating revenue for Q1 2022 was RMB 146.39 million, representing a growth of 24.25% year-over-year[16]. - Net profit attributable to shareholders for Q1 2022 was RMB 21.00 million, a 35.11% increase compared to the same period last year[16]. - The company's overall gross margin improved to 80.53%, up 2.54 percentage points from 77.99% in the previous year[17]. - Cash flow from operating activities for Q1 2022 was RMB 41.67 million, a significant increase of 843.29% year-over-year[18]. - The net profit after deducting non-recurring gains and losses was RMB 16.85 million, reflecting a growth of 16.91% year-over-year[16]. - Total revenue for Q1 2022 reached ¥146,385,175.70, an increase from ¥117,814,952.19 in Q1 2021, representing a growth of approximately 24.3%[95]. - The net profit for Q1 2022 was ¥21,002,890.48, representing a 35% increase from ¥15,545,169.76 in Q1 2021[97]. - The company's total profit for Q1 2022 was ¥25,256,081.75, compared to ¥18,908,857.19 in Q1 2021, marking a 33% increase[96]. - The operating profit for Q1 2022 was ¥25,293,248.56, an increase of 32% from ¥19,069,602.22 in Q1 2021[96]. - The total comprehensive income for Q1 2022 was ¥21,002,890.48, compared to ¥15,545,169.76 in Q1 2021, showing a growth of 35%[97]. Assets and Liabilities - Total assets as of March 31, 2022, reached RMB 886.63 million, an increase of 5.80% compared to the end of 2021[16]. - Total liabilities rose to ¥169,516,543.83, up from ¥146,568,023.42, indicating an increase of approximately 15.6%[89]. - Current liabilities totaled ¥138,626,755.19, compared to ¥115,446,207.16, marking an increase of around 19.9%[89]. - Non-current liabilities decreased slightly to ¥30,889,788.64 from ¥31,121,816.26, showing a decline of about 0.7%[89]. - Shareholders' equity increased to ¥717,114,651.10 from ¥691,454,933.84, reflecting a growth of approximately 3.7%[89]. Shareholder Information - The total number of unrestricted shares increased from 19,847,926 to 43,878,944, representing a growth from 30.40% to 67.21% of total shares[24]. - The total number of restricted shares decreased from 45,438,074 to 21,407,056, changing from 69.60% to 32.79% of total shares[24]. - The largest shareholder, Li Yong'an, holds 6,761,216 shares, accounting for 10.36% of total shares[24]. - The company has 6,494 shareholders as of the end of the reporting period[24]. Cash Flow and Investments - Cash and cash equivalents were reported at ¥410,878,051.29, up from ¥368,291,060.02 at the end of 2021, indicating an increase of about 11.6%[87]. - Cash flow from operating activities for Q1 2022 was CNY 41,667,684.10, a significant increase from CNY 4,417,269.24 in Q1 2021, representing a growth of approximately 841%[101]. - Cash inflow from investment activities in Q1 2022 totaled CNY 31,466,927.14, a substantial rise from CNY 6,755,540.21 in Q1 2021, marking an increase of around 366%[102]. - The ending cash and cash equivalents balance for Q1 2022 was CNY 408,813,822.65, up from CNY 362,587,768.60 in Q1 2021, reflecting an increase of about 13%[102]. Research and Development - Research and development expenses increased to ¥14,753,104.23 in Q1 2022, up from ¥11,845,387.19 in Q1 2021, reflecting a growth of 24%[96]. - The company emphasizes the importance of R&D investment and market expansion to enhance competitiveness and sustainable profitability, focusing on endocrine therapy drug development[50]. Corporate Governance and Compliance - The company has not faced any litigation or arbitration matters during the reporting period[28]. - The company has committed to avoiding any business activities that directly compete with its existing products, ensuring no conflicts of interest with its controlling shareholders[78]. - The controlling shareholders have pledged to minimize and regulate related party transactions, ensuring that any unavoidable transactions adhere to market principles and fair pricing[80]. - The company will strictly fulfill all public commitments made during this issuance and actively accept social supervision[72]. Profit Distribution and Shareholder Returns - The company has committed to a profit distribution policy that ensures cash dividends will not be less than 20% of the distributable profits for the year, with a cumulative cash distribution of at least 60% of the average annual distributable profits over the last three years[56]. - The company plans to review its shareholder dividend return plan at least every three years after listing on the selected tier, considering feedback from shareholders, independent directors, and external supervisors[57]. - The company has a strong profitability and capital management capability, allowing it to provide stable and reasonable returns to shareholders[57]. - The company emphasizes a cash dividend as the primary method of profit distribution, maintaining a focus on shareholder returns[56]. Future Commitments and Plans - The company plans to invest up to 100 million RMB of idle funds in low-risk financial products within 12 months to enhance fund utilization efficiency[31]. - The company intends to use up to 284.19 million RMB of idle raised funds to purchase principal-protected bank products, also within a 12-month period[32]. - The company signed an agreement to acquire a 55% stake in Tongli Haiyuan Biotechnology Co., Ltd. for 155 million RMB, which was approved by the shareholders' meeting[33].
德源药业(832735) - 2021 Q4 - 年度财报
2022-03-29 16:00
Financial Performance - The company's operating revenue for 2021 was CNY 513,824,638.88, representing a 29.56% increase compared to CNY 396,602,667.36 in 2020[39]. - The net profit attributable to shareholders for 2021 was CNY 77,890,698.51, which is a 21.67% increase from CNY 64,020,505.23 in 2020[39]. - The total assets increased by 92.06% to CNY 838,022,957.26 at the end of 2021, compared to CNY 436,336,503.79 at the beginning of the year[41]. - The company's total liabilities at the end of 2021 were CNY 146,568,023.42, a 40.60% increase from CNY 104,245,605.74 at the beginning of the year[41]. - The weighted average return on equity based on net profit attributable to shareholders was 13.02% in 2021, down from 21.09% in 2020[39]. - The net cash flow from operating activities for 2021 was CNY 91,040,912.13, a 65.64% increase from CNY 54,964,047.39 in 2020[43]. - The gross profit margin for 2021 was 78.21%, down from 82.54% in 2020[39]. - The company's total revenue for 2021 was CNY 513,824,638.88, with a net profit attributable to shareholders of CNY 79,895,126.27, reflecting a decrease of 2.51% compared to the preliminary report[48]. - The net profit after deducting non-recurring gains and losses was CNY 70,826,123.99, down 3.25% from the preliminary report[49]. - The company achieved a basic earnings per share of CNY 1.34, which is a decrease of 2.24% compared to the preliminary report[49]. Share Issuance and Capital Structure - The company successfully issued 16,867,000 shares at a price of 18.30 CNY per share, raising a net amount of 284.19 million CNY[4]. - The company has been approved for the issuance of up to 17,476,550 new shares, with the approval valid for 12 months from the date of issuance[4]. - The total share capital of the company is 65,286,000 shares, traded on the Beijing Stock Exchange[30]. - The company's total share capital increased to 65,286,000 shares by the end of 2021, up 43.20% from 45,591,000 shares at the beginning of the year[46]. - The company completed the issuance of shares to unspecified qualified investors, increasing its share capital by 1,969.50 million yuan and capital reserves by 30,904.30 million yuan[82]. Product Development and R&D - The company has over 20 products in various stages of research and development, focusing on diabetes, hypertension, and other metabolic diseases[18]. - The company has established a stable R&D team, but competition for talent may lead to the loss of core technical personnel, impacting long-term development[21]. - The company is committed to enhancing its R&D capabilities, which are seen as a core competitive advantage, despite the associated short-term financial strain[69]. - The company is focusing on expanding its presence in the biopharmaceutical sector, particularly in diabetes treatment, through strategic investments and collaborations[116]. - The company plans to maintain its investment in R&D, targeting new product approvals each year, with a goal to complete the consistency evaluation of its product Canagliflozin Hydrochlorothiazide in 2022[158][159]. Market and Competition - The pharmaceutical industry is experiencing intensified competition, particularly in the diabetes medication sector, which is expected to continue growing due to rising patient awareness and treatment rates[15]. - The company is adapting to the new market environment driven by the normalization of centralized procurement and the need for quality improvement[151]. - The focus on high-quality, cost-effective therapeutic products will benefit companies that can control costs effectively[151]. - The company is committed to enhancing product quality and market promotion to improve market share amidst increasing competition[175]. - The company is experiencing rising production costs due to increased safety and environmental regulations, as well as significant price hikes in raw materials[70]. Regulatory and Compliance - The company is subject to significant regulatory risks, including the potential failure of clinical trials or bioequivalence studies, which could adversely affect research and development progress[19]. - The pharmaceutical industry is highly regulated, and changes in policies could adversely affect the company's operations if it fails to adapt[20]. - The company is actively investing in environmental protection measures to comply with increasingly stringent regulations, which may lead to higher operational costs[16]. - The company has implemented an environmental self-monitoring plan in accordance with the pollutant discharge permit requirements[140]. - The company has established an emergency response plan for environmental incidents, which was approved by experts and filed with the local ecological environment bureau[146]. Sales and Marketing - The company’s marketing strategy emphasizes academic promotion to enhance product recognition among healthcare professionals and patients[58]. - The revenue from diabetes products increased by 24.20% compared to the previous year, driven by enhanced sales efforts and the successful promotion of key products like the sustained-release metformin tablets, which saw significant sales growth of 82.44%[99]. - Major customers accounted for 53.84% of total sales, with the largest customer, China National Pharmaceutical Group, contributing 23.02%[103]. - The company is focusing on optimizing its product sales structure, with significant growth in key promoted products[60]. - The company plans to continue promoting new products to drive sales growth and increase profit margins[58]. Environmental Responsibility - The company is committed to enhancing its environmental protection efforts in response to increasing regulatory requirements and public awareness[179]. - The company’s COD emissions were recorded at 1.784 tons, significantly below the discharge standard of 500 mg/L[141]. - The company’s ammonia nitrogen emissions were 0.2892 tons, well within the limit of 45 mg/L[141]. - The company’s total nitrogen emissions were 0.1704 tons, below the discharge standard of 70 mg/L[141]. - The company’s total phosphorus emissions were 0.0196 tons, significantly lower than the limit of 8 mg/L[141]. Social Responsibility - The company provided RMB 15,000 in aid to 20 underprivileged families before the 2021 Spring Festival, contributing to social responsibility efforts[139]. - The company actively supports local education by providing RMB 6,000 scholarships to five new college students in 2021[139]. - The company emphasizes a harmonious work environment and comprehensive employee benefits, including full coverage of social insurance[138]. - The company has not reported any major safety incidents during the reporting period, but continues to invest in safety and environmental protection measures[178]. Talent Management - The company is focused on enhancing its talent pool to support future growth, although it currently faces challenges in attracting and retaining high-level technical and management personnel[16]. - The company implemented a restricted stock incentive plan in 2021, granting 2,828,000 shares to 128 core employees and senior management to enhance employee motivation and retention[176]. - There is a risk of talent shortages in the company, which is crucial for sustaining growth and innovation in the technology-intensive pharmaceutical sector[175]. - The total number of R&D personnel increased from 96 to 128, with the proportion of R&D staff to total employees rising from 12.00% to 14.22%[123]. Future Outlook - The company anticipates long-term growth in the pharmaceutical industry supported by rising consumer spending and an aging population, despite short-term adjustment pressures[68]. - Future product launches are expected to provide new profit growth points, contributing to the company's long-term competitiveness[128]. - The company aims to establish itself as a leading pharmaceutical enterprise in the endocrine field, focusing on product marketing and research and development[156]. - The company faces significant uncertainties in achieving its 2022 operational plan, particularly due to the evolving nature of local procurement rules and the impact of centralized procurement policies[171]. - The integration of Tongli Haiyuan is critical for future growth, with risks related to business synergy and operational alignment[172].