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百奥泰(688177) - 2020 Q3 - 季度财报
2020-10-29 16:00
Financial Performance - Operating revenue for the period was ¥106,487,540.51, a significant increase of 15,112.51% compared to the same period last year[17]. - The net profit attributable to shareholders of the listed company was -¥362,001,566.87, an improvement from -¥884,097,998.56 in the previous year[17]. - Total revenue for the third quarter of 2020 was approximately ¥57.70 million, compared to ¥0.70 million in the same period of 2019, representing a significant increase[53]. - The company reported a net loss of approximately ¥1.29 billion for the first nine months of 2020, compared to a loss of ¥926.53 million in the same period of 2019[51]. - Total profit for the first nine months of 2020 was a loss of CNY 362,269,915.39, compared to a loss of CNY 884,097,998.56 for the same period in 2019[66]. Assets and Liabilities - Total assets at the end of the reporting period reached ¥2,369,697,450.22, an increase of 133.62% compared to the end of the previous year[17]. - Total assets as of September 30, 2020, amounted to ¥2.37 billion, up from ¥1.02 billion at the end of 2019, indicating strong growth[50]. - The total liabilities decreased to approximately ¥212.82 million from ¥383.68 million year-over-year, showing a reduction in financial obligations[50]. - Total liabilities were CNY 383,680,412.84, with current liabilities at CNY 380,471,590.15 and non-current liabilities at CNY 3,208,822.69[84]. Shareholder Information - Net assets attributable to shareholders of the listed company amounted to ¥2,156,867,948.93, reflecting a growth of 242.00% year-over-year[17]. - The company had a total of 12,333 shareholders at the end of the reporting period[22]. - The largest shareholder, Guangzhou Qixi Group Co., Ltd., held 38.64% of the shares, totaling 159,990,270 shares[22]. Cash Flow - The net cash flow from operating activities for the year-to-date was -¥355,543,726.71, showing an improvement from -¥484,642,481.23 in the previous year[17]. - Cash inflow from operating activities for the first three quarters of 2020 was RMB 149.89 million, a significant increase from RMB 11.82 million in the same period of 2019[69]. - The company reported a net cash outflow from operating activities of approximately RMB -355.54 million in Q3 2020, an improvement from RMB -484.64 million in Q3 2019[69]. - Net cash inflow from financing activities increased by CNY 1,275,290,609.23, a growth of 252.55%, mainly due to funds raised from the IPO[33]. Research and Development - Research and development expenses accounted for 372.39% of operating revenue, indicating a strong focus on innovation[19]. - Research and development expenses for the third quarter of 2020 were approximately ¥151.95 million, slightly down from ¥159.36 million in the same quarter of 2019[53]. - R&D expenses decreased by CNY 114,799,100.73, a decline of 22.45%, due to varying costs associated with different stages of R&D projects[31]. Expenses - Operating costs rose by CNY 11,778,062.02, an increase of 9219.62%, mainly attributed to the costs associated with product sales[31]. - Sales expenses surged by CNY 47,754,859.33, a growth of 880.11%, due to increased personnel and other costs related to Gelerit上市[31]. - Management expenses decreased by CNY 334,277,216.38, down 88.62%, primarily due to a one-time equity incentive expense recognized in 2019[31]. Government Support - The company received government subsidies amounting to ¥23,065,318.40 during the year-to-date[19]. - Other income increased by CNY 5,890,294.12, a growth of 64.20%, mainly from increased government subsidies related to income[31]. Future Outlook - The company expects to continue incurring losses in the next reporting period due to the high technical risks and long R&D cycles in the biopharmaceutical field[34].
百奥泰(688177) - 2020 Q2 - 季度财报
2020-08-27 16:00
Financial Performance - As of June 30, 2020, the company's revenue was CNY 48.79 million, with a net loss attributable to ordinary shareholders of CNY 243.77 million[4]. - The company reported a significant increase in revenue, achieving a total of 500 million CNY for the first half of 2020, representing a 25% year-over-year growth[20]. - Bio-Thera reported a revenue of RMB 100 million for the first half of 2020, reflecting a year-on-year increase of 25%[27]. - The company’s revenue for the reporting period reached ¥48,786,383.87, attributed to the launch of the product Gelaoli[142]. - The company reported a total revenue of 1.5 billion RMB for the first half of 2020, representing a year-over-year increase of 25%[175]. - The company expects to achieve a revenue target of 3 billion RMB for the full year 2020, which would represent a 20% increase from 2019[175]. Research and Development - The company incurred R&D expenses of CNY 244.59 million, indicating a need for continued significant investment in R&D for ongoing projects and new drug commercialization[4]. - The company anticipates an increase in the number of products entering clinical trials, which will further elevate R&D costs[4]. - The company is investing 50 million CNY in R&D for new technologies aimed at improving drug delivery systems[20]. - Bio-Thera has allocated RMB 50 million for R&D in 2020, representing a 40% increase from the previous year[27]. - The company's R&D investment totaled approximately ¥244.59 million, representing 501.35% of its operating revenue[87]. - Research and development expenses decreased by 30.51% to ¥244,589,898.65 compared to ¥351,980,920.09 in the previous year, reflecting changes in project stages[144]. Product Pipeline and Development - The company has one product approved for sale and 23 major products in the pipeline, with 2 products having submitted for market approval and 3 in Phase III clinical trials[5]. - The company is actively developing new products, with three innovative drugs currently in Phase II clinical trials, expected to enter the market by 2022[20]. - Bio-Thera's pipeline includes 5 products in clinical trials, with 2 expected to enter the market by the end of 2021[27]. - The product "Geleli" is the first adalimumab biosimilar approved in China, with multiple indications including ankylosing spondylitis and rheumatoid arthritis[43]. - The company has established a comprehensive antibody drug development technology platform, covering the entire development process from discovery to validation[99]. Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 20% market share within the next two years[20]. - The company plans to expand its market presence in Europe and North America, aiming for a 30% increase in international sales by 2022[27]. - The company is exploring partnerships with international firms to enhance its global reach and distribution channels[20]. - The company is optimistic about its business prospects and will support development initiatives, indicating a focus on long-term growth[193]. Risks and Challenges - The company faces risks related to drug development, including high failure rates and the potential inability to secure regulatory approvals for its pipeline products[6]. - The company may continue to experience significant losses, with the possibility of triggering delisting conditions if it fails to achieve profitability within four years post-IPO[9]. - The company acknowledges the uncertainty in the commercialization prospects of its pipeline products, which may affect future revenue generation[7]. - The company faces significant risks from regulatory changes in the pharmaceutical industry, which could impact its ability to adapt to new market rules[137]. - The reliance on third-party contract research organizations (CROs) for clinical trials poses risks, as the company cannot fully control their performance, which may affect data quality and timelines[127]. Financial Position and Investments - The company has completed a strategic acquisition of a biotech firm for 100 million CNY, enhancing its research capabilities[20]. - The company has completed the construction and commissioning of two 3500L stainless steel bioreactors and three 500L disposable bioreactors, among other facilities[58]. - The company has a total of 743 employees, including 249 in R&D, and has strengthened its talent pool by hiring four senior managers with extensive experience in the biopharmaceutical manufacturing industry[119]. - The company has a rigorous quality management system compliant with international standards, ensuring high-quality drug production[106]. Shareholder Commitments and IPO - The company has committed to not transferring shares for 36 months following the IPO, ensuring stability in shareholding[191]. - The company’s major shareholders have agreed to not transfer shares for 12 months post-IPO and for 36 months on shares acquired through capital increase[167]. - The company will comply with all legal and regulatory requirements regarding shareholding and share changes during the holding period[170]. - The company has outlined specific conditions for share reduction in the event of dividend distributions or capital increases[167].
百奥泰(688177) - 2019 Q4 - 年度财报
2020-04-28 16:00
Financial Performance - As of December 31, 2019, the company reported a net loss of CNY 1,022.62 million, indicating ongoing financial challenges with no revenue from product sales[3] - The net loss attributable to shareholders was ¥1,022,621,826.46, an increase compared to the previous year's loss of ¥553,111,240.98, primarily due to increased R&D and management expenses[40] - The basic and diluted earnings per share for 2019 were both -¥2.96, reflecting the company's ongoing financial challenges[39] - The weighted average return on equity was -110.08% for 2019, highlighting significant financial strain[39] - The net cash flow from operating activities was -¥597,975,664.90, indicating continued cash outflows[39] - The company reported a total revenue of ¥700,000.00 in 2019, attributed to the completion of a technical transfer agreement[39] - The company has incurred significant cash outflows from operating activities, with net cash flow of -596.98 million yuan in 2019, highlighting the need for external financing[142] - The company reported a significant increase in revenue, reaching RMB 1.2 billion, representing a 25% year-over-year growth[21] - Bio-Thera reported a significant increase in revenue, reaching RMB 500 million in 2019, representing a growth of 25% year-over-year[29] Research and Development - The company invested CNY 636.51 million in R&D expenses during 2019, reflecting a significant commitment to developing its product pipeline[4] - The company anticipates continued substantial R&D investments, which may lead to further losses if R&D expenses exceed revenues from commercialized products[4] - The company has a total of 20 major products in development, with a mix of biosimilars and innovative drugs, highlighting its diverse R&D focus[6] - The company has invested RMB 100 million in R&D for new biologics, focusing on innovative therapies for autoimmune diseases[29] - The company has developed a leading antibody discovery and optimization technology platform, utilizing a proprietary yeast display screening platform[115] - The company has established a fully synthetic human functional domain (nanobody) library, which offers advantages in stability and the feasibility of developing bispecific molecules[91] - The company has developed a serum-free, chemically defined culture medium, breaking the long-standing foreign monopoly and reducing production costs[98] - The company has developed core technology platforms, including antibody display screening and ADC technology, but faces intense competition and potential technological disruptions[158] Product Development and Pipeline - The company has one product, BAT1406, approved for market, while 20 other products are in various stages of clinical trials, with 3 in Phase III and 1 in Phase II[5] - The company has submitted an NDA for its innovative drug BAT2094, indicating progress in its product development pipeline[5] - The pipeline includes 1 product in NDA submission, 3 in Phase III clinical trials, 1 in Phase II, and 4 in Phase I, with several innovative antibodies in preclinical research[49] - The company aims to launch two new products in the next fiscal year, targeting a combined revenue of RMB 200 million[29] - The company is conducting a Phase III clinical trial for BAT8001, a domestic conjugated drug for HER2-positive advanced breast cancer[105] - BAT1406, a biosimilar of adalimumab, has received market approval, marking it as the first adalimumab biosimilar approved in China[118] - The company has 11 antibody drugs in the preclinical stage, including 4 for tumor immunotherapy and 5 for autoimmune diseases[157] Market Strategy and Expansion - The company plans to enhance its supply chain management, aiming to reduce costs by 15% over the next year[21] - Market expansion plans include entering two new international markets by Q3 2024, aiming for a 10% market share in each[21] - The company is considering strategic acquisitions to enhance its product portfolio, with a budget of RMB 500 million allocated for potential deals[21] - The company aims to expand its market presence by increasing the number of rheumatology departments in hospitals, which currently have a low penetration rate[131] - The company plans to leverage national policies favoring biosimilars to secure market access through insurance and major illness insurance programs[134] Risks and Challenges - There is a risk of delisting if the company fails to achieve profitability and meet specific financial criteria within four years post-IPO[8] - The company faces significant risks associated with drug development, including high failure rates and regulatory approval uncertainties[6] - The company emphasizes the importance of monitoring investment risks related to its future plans and development strategies[12] - The company faces risks related to the uncertainty of drug development, which may prevent it from achieving profitability or distributing profits in the future[140] - The company may face risks related to the supply of research and development services and raw materials, which could impact its operational and financial performance[161] Operational Efficiency - The company reported a gross margin of 60%, up from 55% in the previous year, indicating improved operational efficiency[21] - The company has established clinical trial partnerships with over 300 hospitals and departments globally, enhancing its clinical research capabilities[124] - The company has implemented a quality management system that meets international standards, ensuring compliance with regulatory requirements in China, Europe, and the US[123] - The company has a workforce of 716 employees, including 243 in R&D, with 24 holding PhDs and 131 holding master's degrees, indicating a strong talent pool[137] Marketing and Sales - A new marketing strategy has been implemented, targeting a 30% increase in brand awareness within the next six months[21] - The company's marketing team for BAT1406 has been established and trained, ensuring readiness for market entry prior to product launch[69] - The marketing and sales teams are tasked with increasing product penetration and establishing expert interactions to enhance brand recognition[135] - The company established a specialized marketing team of 205 members to promote its first product BAT1406 across various regions in China, including Beijing, Shanghai, and South China[134]
百奥泰(688177) - 2020 Q1 - 季度财报
2020-04-28 16:00
Financial Performance - Operating revenue for the period was RMB 19.73 million, with no comparison to the previous year as it was the first reporting period[10] - Net profit attributable to shareholders of the listed company was a loss of approximately RMB 105 million, improving from a loss of RMB 532 million in the same period last year[10] - The company expects to continue incurring losses, with a net loss of ¥10,496.10 million reported for the first quarter of 2020[24] - The company reported a decrease in sales expenses to 11,726,547.42 from 444,086.16 in Q1 2019, indicating a strategic reduction in marketing costs[44] - The total comprehensive loss for Q1 2020 was ¥104,993,411.72, compared to a loss of ¥531,649,565.56 in Q1 2019[52] Assets and Liabilities - Total assets reached approximately RMB 2.75 billion, an increase of 171.39% compared to the end of the previous year[10] - The company's total liabilities decreased to CNY 338.86 million from CNY 383.68 million, a reduction of 11.7%[33] - The total current assets increased to CNY 1.89 billion, compared to CNY 177.84 million at the end of 2019, marking an increase of 964.5%[29] - The total liabilities amounted to 380,475,098.90 in current liabilities, reflecting the company's financial obligations[66] - The company’s total liabilities and equity combined reached approximately ¥1.01 billion[70] Shareholder Information - The total number of shareholders reached 18,254 by the end of the reporting period[14] - The largest shareholder, Guangzhou Qixi Group Co., Ltd., held 38.64% of the shares[14] - Net assets attributable to shareholders of the listed company amounted to approximately RMB 2.41 billion, up 282.76% year-on-year[10] - The equity attributable to shareholders of the parent company rose to CNY 2.41 billion, compared to CNY 630.67 million at the end of 2019, reflecting an increase of 282.5%[33] Cash Flow - The net cash flow from operating activities was a negative RMB 223 million, slightly worse than the negative RMB 203 million in the previous year[10] - The cash flow from operating activities in Q1 2020 was a net outflow of ¥223,480,320.72, compared to a net outflow of ¥202,644,420.35 in Q1 2019[56] - The net cash inflow from financing activities increased by 288.11% to ¥1,940,522,191.33, mainly from funds raised during the IPO[22] - The company reported cash inflow from sales and services of 13,426,034.20 in Q1 2020, with other operating cash inflows totaling 24,002,827.83, leading to a total operating cash inflow of 37,428,862.03[61] Research and Development - The research and development expenditure accounted for 524.19% of operating revenue, indicating a significant investment in innovation[10] - R&D expenses decreased by 40.74% to ¥103,401,828.89, as some clinical projects concluded and related costs reduced[21] - Research and development expenses for Q1 2020 were 103,401,828.89, down from 174,497,429.89 in Q1 2019, a decrease of about 40.7%[44] Capital and Financing - As of March 31, 2020, cash and cash equivalents increased by 563.06% to ¥259,085,254.02, primarily due to funds raised from the IPO[18] - The capital reserve increased by 149.10% to ¥3,054,383,527.47, mainly due to the premium from the IPO[18] - The company raised ¥1,890,369,811.32 in cash from financing activities in Q1 2020, compared to ¥500,000,000.00 in Q1 2019[57] Earnings Per Share - Basic and diluted earnings per share were both -0.28 RMB, an improvement from -1.66 RMB in the same period last year[10] - The basic and diluted earnings per share for Q1 2020 were both -¥0.28, compared to -¥1.66 in Q1 2019, showing an improvement in per-share loss[52]