HYBIO(SZ:300199)2024-04-26 16:03Financial Performance - Net profit attributable to shareholders decreased by 38.68% year-on-year in 2023, primarily due to significant price reductions of key products entering centralized procurement and delayed international business contracts contributing minimally to 2023 profits[7] - Quarterly revenue declined from 176,222,802.86 in Q1 to 29,828,864.39 in Q4, with net profit turning from 18,605,574.69 in Q1 to -333,326,785.70 in Q4[13] - Revenue in 2023 decreased by 38.75% to 431,384,112.87 yuan compared to 704,321,731.88 yuan in 2022[65] - Net profit attributable to shareholders in 2023 was -513,876,149.69 yuan, a decrease of 38.68% from -370,550,318.41 yuan in 2022[65] - Operating cash flow in 2023 was -3,536,573.51 yuan, a decrease of 122.37% from 15,807,431.54 yuan in 2022[66] - Total assets at the end of 2023 decreased by 9.25% to 3,277,193,711.56 yuan from 3,611,233,247.62 yuan at the end of 2022[66] - Net assets attributable to shareholders at the end of 2023 decreased by 40.28% to 758,803,660.30 yuan from 1,270,636,709.44 yuan at the end of 2022[66] - The company's net profit attributable to shareholders for the year was -354,843,109.53 RMB, with a significant loss in the fourth quarter[59] - The company's recent three fiscal years have shown negative net profits after deducting non-recurring gains and losses, raising concerns about its ongoing operational capabilities[57] - The company's non-current asset disposal losses in 2023 amounted to -2,322,023.63 thousand yuan, compared to a gain of 2,913,871.36 thousand yuan in 2022 and 34,994,359.55 thousand yuan in 2021[90] - The company reported a net profit attributable to the parent company of -51,387.61 thousand yuan in 2023, accounting for 40.44% of the net assets at the end of the previous year[107] Product Development and R&D - The company is collaborating with the Chinese Academy of Sciences to develop a COVID-19 peptide nasal spray drug (HY3000)[31] - A partnership with the Chinese CDC aims to develop a peptide vaccine (HY3001) based on two patented technologies[31] - The company is working with Shenzhen Third People's Hospital to develop a COVID-19 antigen detection kit (HY3002)[31] - The company is involved in the development of new drugs, including Cabergoline and Atosiban, which are in various stages of clinical trials[49] - The company received approval for clinical trials of Semaglutide Injection from the National Medical Products Administration on December 4, 2023[69] - The company's Semaglutide Injection received clinical approval for diabetes treatment in December 2023[169] - The company's Vildagliptin Tablets, Octreotide Acetate Injection, and Terlipressin Injection were approved for market release in January 2023, with Terlipressin Injection indicated for esophageal variceal bleeding[161][162][163] - The company's injection of Cetrorelix Acetate was approved and passed consistency evaluation in July 2023[167] - Linaclotide capsule received clinical approval in May 2023[190] - Carbetocin injection was approved for new vaginal secretion indication in July 2023[192] - HY3000 nasal spray received clinical approval for treating mild to moderate COVID-19 in September 2023[193] - COVID-19 antigen test kit (latex method) was approved in September 2023[194] - Desmopressin acetate injection passed consistency evaluation in October 2023[195] - The company's HY3000 nasal spray, a novel peptide fusion inhibitor, demonstrated significant anti-COVID-19 effects in preclinical studies, showing strong inhibitory activity against multiple variants including Delta, Omicron BA.1, BA.2, and BA.4[167] - The company's R&D innovation focuses on weight loss, diabetes, and women's reproductive health products, as well as API export business[138] - The company's future development plans, product advantages, and R&D strengths were discussed with 25 investors[141] - The company's R&D investment, API business progress, and innovation drug development were discussed with institutional investors[141] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] International Business and Strategy - International business contracts, mainly scheduled for 2024, contributed minimally to 2023 profits[7] - The company's overseas sales continued to grow in 2023, with the successful export of Liraglutide preparations and GLP-1 APIs, marking the initial success of its "Global Vision, Local Roots" international strategy[158] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] Corporate Structure and Operations - The company's subsidiaries include Hong Kong HanYu, Wuhan HanYu, and Chengji Pharmaceutical, among others[27] - The company's operations span multiple locations, including Longhua headquarters, Pingshan branch, and Nanshan branch[27] - The company's stock code is 300199, and it is listed on the Shenzhen Stock Exchange[52] - The company's registered and office address is located in the Longhua District, Shenzhen, China[52] - The company's annual report is disclosed on major financial media platforms such as the Securities Times and the China Securities Journal[54] - The company's website is http://www.hybio.com.cn, and its email is hy@hybio.com.cn[52] - The company's legal representative is Zeng Shaogui[52] - The company's controlling shareholder and actual controller did not change during the reporting period[79][81] - The company's production model is based on "sales-driven production + small inventory" to ensure timely delivery[150] - The company's sales model includes direct sales and intermediary trade for APIs, and distribution and licensing for formulations[151] - The company has a leading position in peptide drug production and development, with a complete and efficient industrialization system[154] - The company has advanced R&D facilities, including over 300 specialized equipment from the US, Germany, and Switzerland[155] - The company has established a comprehensive quality management system, achieving 100% training qualification for employees and 100% compliance with registered process requirements[157] - The company has passed multiple certifications including China GMP, US FDA, Brazil, and EU certifications, and has undergone numerous audits and inspections by domestic and international regulatory bodies[157] - The company was listed among the top 500 manufacturing enterprises in Guangdong in 2023 and recognized as a "Specialized and Sophisticated" enterprise in Shenzhen[157] - The company's Wuhan subsidiary was awarded the title of "Outstanding Advanced Manufacturing Enterprise" in Huangpi District[157] Shareholder and Stock Information - The company canceled 33,685,704 shares in 2023, reducing the total number of shares from 699,719,517 to 666,033,813[72] - The proportion of restricted shares increased from 23.69% to 24.59% in 2023[71] - The top three shareholders, Zeng Shaogui, Zeng Shaoqiang, and Zeng Shaobin, held a total of 217,207,523 restricted shares at the end of 2023[74] - The company plans not to distribute cash dividends, issue bonus shares, or convert capital reserve into share capital[40] Government Subsidies and Non-Recurring Items - Government subsidies recognized in 2023 were 49,872,754.40 thousand yuan, a significant increase from 25,754,136.38 thousand yuan in 2022 and 46,683,413.96 thousand yuan in 2021[90] - The company's total non-recurring gains and losses in 2023 were 77,037,520.69 thousand yuan, compared to -56,025,540.62 thousand yuan in 2022 and 430,777,698.31 thousand yuan in 2021[91] - The company's financial assets and liabilities generated a fair value change and disposal gain of 31,511,232.36 thousand yuan in 2023, compared to losses of -82,559,111.99 thousand yuan in 2022 and -19,006,481.51 thousand yuan in 2021[91] - The company's other non-operating income and expenses in 2023 were -1,788,927.17 thousand yuan, compared to -1,517,471.56 thousand yuan in 2022 and -5,220,011.58 thousand yuan in 2021[91] - The company's long-term equity investment conversion to financial instruments generated an investment income of 376,846,594.64 thousand yuan in 2021[91] - The company's income tax impact in 2022 was 589,461.21 thousand yuan, compared to 3,252,501.84 thousand yuan in 2021[91] - The minority shareholders' equity impact in 2022 was 27,503.60 thousand yuan, compared to 267,674.91 thousand yuan in 2021[91] Intellectual Property and Patents - The company has nearly 400 domestic patents and dozens of international patents, and was recognized as an intellectual property advantage enterprise in 2022[133] - The company obtained 20 domestic patents in 2023, including patents for GLP-1 analog salt conversion and purification methods, as well as a solid-phase synthesis method for disulfide-bonded peptide drugs[170][172][173] - The parent company holds 277 domestic patents, including 271 invention patents, as of December 31, 2023[196] - A fully automatic injection pen was patented by Gansu Chengji Bio-Pharmaceutical Co., Ltd. in December 2016[200] Product Portfolio and Market Position - The company has 28 peptide drugs, 9 new drug certificates, and 31 clinical approvals, with a leading domestic market share for products like Terlipressin for Injection and Somatostatin for Injection[135] - The company's peptide API business is expected to grow steadily as global API market recovers and peptide drug patents expire, with 16 US DMFs, 5 EU DMFs, 5 EU CEPs, and 14 China DMFs[127] - Hanbei® Atosiban Acetate Injection received EU market approval in 2020 and passed the generic drug consistency evaluation in 2022[126] - The company has 16 products that have passed the generic drug consistency evaluation, including 11 peptide injections and 5 small molecule solid preparations[135] - The company's Desmopressin Acetate Injection is listed in the essential drug catalog and has advantages in market promotion[122] - The company's Carbetocin Injection has higher bioavailability and longer-lasting effects compared to traditional oxytocin, reducing the need for additional therapeutic uterotonics[124] - The company's Oxytocin Injection is a fourth-generation product with higher purity and fewer adverse reactions, meeting the 2015 Pharmacopoeia standards[123] - The company has established a high technical barrier in peptide API synthesis with over 20 years of experience, and strong customer loyalty, especially for products like Liraglutide[127] - The company implements strict quality control measures and risk management systems to ensure product quality and safety, including regular internal inspections and risk assessments[137] - Vildagliptin tablets are approved for monotherapy when diet and exercise fail to control blood sugar, and for combination therapy with metformin, insulin, or sulfonylureas when these treatments alone are insufficient[188] - Octreotide acetate injection is approved for controlling symptoms in acromegaly patients and treating bleeding from esophageal varices in cirrhosis patients[188] - Oxytocin injection passed consistency evaluation in March 2023[189]