LUYE PHARMA(02186)

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2024年CNS领域帕里哌酮有望实现中美上市,全球商业化产品增多
天风证券· 2024-04-09 16:00
Investment Rating - The report maintains a "Buy" rating for the company [1] Core Viewpoints - The company is expected to achieve dual listings for its product Paliperidone in China and the US, with an increase in global commercialization of its products [1] - The overall performance for 2023 met expectations, with total revenue of 6.14 billion RMB, a year-on-year increase of 2.7%, and product sales revenue of 5.63 billion RMB, a year-on-year increase of 11.2% [1] - The decline in net profit to 533 million RMB, a decrease of 11.9% year-on-year, is attributed to a lower proportion of licensing income [1] - The company anticipates the approval of five new products in 2024, contributing to a continuous increase in new product numbers [1] - The launch of innovative drug Zepzelca in Hong Kong and Macau has broken the treatment bottleneck for SCLC [1] - The company’s operational efficiency is expected to improve, leading to an increase in net profit margin [1] Summary by Relevant Sections Financial Performance - In 2023, the revenue from oncology treatment reached 1.92 billion RMB, a year-on-year increase of 26.3%, while revenue from CNS treatment was 1.39 billion RMB, up 14.8% [1] - The cardiovascular treatment revenue was 1.69 billion RMB, reflecting a year-on-year growth of 10.8% [1] - The overall net profit margin improved in the second half of 2023, reaching 12.2%, an increase of 7.2 percentage points compared to the first half [1] Product Pipeline - The company has several products expected to be approved in 2024, including: - Lurbinectedin (LY01017) for small cell lung cancer - Oxycodone Naloxone (LY021702) for moderate to severe chronic pain - Rotigotine microspheres (LY03003) for Parkinson's disease - Paliperidone (LY03010) for schizophrenia in both China and the US - Dexamethasone (BA1102) for solid tumor bone metastases and giant cell tumor [3] Future Outlook - The company is projected to achieve revenues of 6.991 billion RMB, 8.529 billion RMB, and 10.279 billion RMB from 2024 to 2026, with net profits of 809 million RMB, 1.373 billion RMB, and 1.678 billion RMB respectively [1]
销售收入快速增长,商业全球化稳步推进
华安证券· 2024-03-31 16:00
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a revenue of 61.43 billion HKD for 2023, a year-on-year increase of 2.70%, with product sales revenue reaching 56.27 billion HKD, reflecting a growth of 11.23% [1] - The net profit attributable to shareholders was 5.33 billion HKD, showing a decline of 11.94% year-on-year [1] - The company has seen continuous improvement in management efficiency and significant optimization of its financial structure [1] - Revenue growth was observed across three major fields, with double-digit growth in product sales recovery [1] - The company launched five new products in 2023, with significant potential for growth in the oncology sector [1][2] Financial Summary - The projected revenues for 2024, 2025, and 2026 are 68.11 billion HKD, 83.95 billion HKD, and 99.25 billion HKD, representing year-on-year growth rates of 11%, 23%, and 18% respectively [2][3] - The net profit attributable to shareholders is expected to be 7.75 billion HKD, 12.40 billion HKD, and 15.98 billion HKD for the years 2024, 2025, and 2026, with corresponding growth rates of 46%, 60%, and 29% [2][3] - The gross margin is projected to improve from 68.44% in 2023 to 73.79% in 2025, before slightly decreasing to 72.94% in 2026 [3][5] - The company’s asset-liability ratio is expected to decrease from 46.93% in 2023 to 36.10% in 2026, indicating a continued effort to reduce debt [5] Product and Market Development - The oncology treatment revenue reached 21.22 billion HKD, while the cardiovascular and central nervous system treatment revenues were 16.87 billion HKD and 16.95 billion HKD, reflecting increases of 10.8% and 28.1% respectively [1] - The company has successfully entered international markets with its cardiovascular products and has maintained a strong market position for its CNS products [1] - Several new products are expected to be approved soon, which will lay a solid foundation for future growth [1][2]
绿叶制药(02186) - 2023 - 年度业绩
2024-03-27 14:53
Financial Performance - Revenue increased by RMB 161.4 million or 2.7% to RMB 6,143.1 million compared to the year ended December 31, 2022[2]. - EBITDA rose by RMB 264.6 million or 14.6% to RMB 2,077.4 million compared to the previous year[2]. - Gross profit increased by RMB 63.7 million or 1.5% to RMB 4,204.2 million, with a gross profit margin of 68.4%[2]. - Profit before tax increased by RMB 30.3 million or 4.5% to RMB 700.1 million compared to the year ended December 31, 2022[2]. - Net profit attributable to shareholders decreased to RMB 532.6 million, a decline of RMB 72.2 million compared to the previous year[2]. - Basic earnings per share decreased to RMB 14.29 from RMB 17.38 in the previous year[2]. - Total revenue for the year ended December 31, 2023, was RMB 6,143,078 thousand, an increase from RMB 5,981,656 thousand in 2022, representing a growth of approximately 2.7%[23][26]. - The pre-tax profit for the year ended December 31, 2023, was RMB 700,100 thousand, compared to RMB 669,762 thousand in 2022, indicating an increase of about 4.5%[21][23]. Assets and Liabilities - Total non-current assets increased to RMB 14,787.4 million from RMB 13,463.8 million in the previous year[6]. - Current assets totaled RMB 10,703.3 million, slightly down from RMB 10,785.8 million in the previous year[6]. - Cash and cash equivalents increased to RMB 3,238.9 million from RMB 2,323.7 million in the previous year[6]. - As of December 31, 2023, total current liabilities decreased to RMB 8,137,807 thousand from RMB 9,487,203 thousand in 2022, representing a reduction of approximately 14.3%[7]. - The net value of current assets increased significantly to RMB 2,565,475 thousand in 2023, compared to RMB 1,298,610 thousand in 2022, marking a growth of approximately 97.6%[7]. - Total assets minus current liabilities rose to RMB 17,352,908 thousand in 2023, up from RMB 14,762,422 thousand in 2022, indicating an increase of about 17.7%[7]. - The total equity attributable to the parent company increased to RMB 12,531,185 thousand in 2023 from RMB 10,175,954 thousand in 2022, reflecting a growth of approximately 23.2%[8]. - The company’s total non-current liabilities amounted to RMB 3,824,414 thousand in 2023, slightly up from RMB 3,720,700 thousand in 2022, indicating a marginal increase of about 2.8%[7]. Revenue Breakdown - The segment revenue from tumor drugs was RMB 5,627,352 thousand for 2023, while the revenue from cardiovascular system drugs was RMB 1,687,359 thousand[22]. - Revenue from sales products amounted to RMB 5,627,352 thousand in 2023, compared to RMB 5,059,298 thousand in 2022, reflecting an increase of about 11.2%[25][26]. - The revenue from R&D services was RMB 81,550 thousand in 2023, up from RMB 86,689 thousand in 2022, indicating a decrease of approximately 6.5%[25][26]. - The total revenue from the Chinese mainland market was RMB 5,029,604 thousand in 2023, a slight decrease from RMB 5,031,164 thousand in 2022, reflecting a marginal decline of approximately 0.03%[25][26]. Expenses and Costs - Administrative expenses for the year were RMB 643,967 thousand, up from RMB 582,870 thousand in 2022, reflecting an increase of approximately 10.5%[21][23]. - The cost of goods sold for 2023 was RMB 1,866,830,000, compared to RMB 1,762,326,000 in 2022, indicating an increase of about 5.9%[30]. - Research and development expenses decreased to RMB 586,157,000 in 2023 from RMB 857,337,000 in 2022, a reduction of approximately 31.6%[30]. - Total financial costs rose to RMB 675,454,000 in 2023, up from RMB 471,755,000 in 2022, marking an increase of about 43.2%[32]. - The total tax expense for the year was RMB 161,023,000, significantly higher than RMB 86,466,000 in 2022, reflecting an increase of approximately 86.2%[35]. Dividends and Share Capital - The board does not recommend the payment of a dividend for the year ended December 31, 2023[2]. - The company did not declare or propose any interim or final dividends for the year ending December 31, 2023, consistent with 2022[38]. - Basic earnings per share for the year were calculated based on 3,728,362,856 shares, an increase from 3,480,852,775 shares in 2022[38]. - The issued share capital rose to RMB 486,107 thousand in 2023, up from RMB 456,953 thousand in 2022, which is an increase of about 6.4%[8]. Research and Development - The R&D team consists of 931 employees, including 86 PhDs and 467 Master's degree holders, as of December 31, 2023[70]. - The company holds 271 patents in China and 508 patents overseas, with 61 and 123 patents pending, respectively[70]. - The company is actively engaged in strategic development in cell therapy and gene therapy[54]. - The company has over 30 domestic and more than 10 international products in the research pipeline[54]. Market and Product Development - The company has established eight production bases globally and maintains a GMP quality management system[54]. - The company has initiated multiple global collaborations, including a partnership with Abacus Medicine Pharma Services for the exclusive distribution of Lurbinectedin in Hong Kong[91]. - The company signed an agreement with Zhengda Qingdao for the exclusive sales rights of Dushudan injection in mainland China in January 2023[91]. - The company completed strategic cooperation with Baijie Shenzhou for the commercialization of its innovative formulation, Goserelin microspheres, in mainland China in July 2023[91]. Future Outlook - The company plans to continue expanding its market presence and investing in new product development to drive future growth[20]. - The group expects existing products to achieve stable growth, with new products approved in the past three years anticipated to ramp up quickly[93]. - The innovative formulation of Baitowei for prostate and breast cancer treatment has been approved for commercialization in China, with a significant market potential estimated at RMB 9.72 billion[94].
绿叶制药(02186) - 2023 - 年度业绩
2023-10-13 14:00
Reward Shares - The total number of reward shares granted in the fiscal year 2022 was 26,389,000, with 25,206,000 shares having vested by May 15, 2022[1] - As of December 31, 2022, there were no unvested reward shares held by the top five highest-paid employees, who collectively held 1,135,000 unvested shares at the beginning of the fiscal year[2] - The closing price of the shares on the stock exchange prior to the vesting date was HKD 2.33 per share[2]
绿叶制药(02186) - 2023 - 中期财报
2023-09-28 14:00
Financial Performance - Revenue increased by RMB 53.3 million or 1.9% to RMB 2,904.1 million compared to the six months ended June 30, 2022[7]. - Gross profit decreased by RMB 106.7 million or 5.2% to RMB 1,943.4 million, with a gross margin of 66.9%[7]. - Net profit attributable to shareholders decreased by RMB 147.0 million or 49.5% to RMB 150.0 million[7]. - EBITDA decreased by RMB 48.7 million or 5.3% to RMB 867.3 million[7]. - The group recorded a significant increase in product sales revenue of 18.7% to RMB 2,784.5 million for the six months ended June 30, 2023, compared to the same period in 2022[9]. - Total revenue, including product sales and licensing agreements, increased by 1.9% to RMB 2,904.1 million during the same period[9]. - In the oncology treatment sector, revenue decreased by 11.2% to RMB 910.3 million, while cardiovascular treatment revenue increased by 24.2% to RMB 977.9 million[10]. - The central nervous system treatment revenue rose by 4.4% to RMB 680.4 million, whereas metabolic treatment revenue decreased by 23.4% to RMB 247.1 million[10]. - The group’s net profit for the six months ended June 30, 2023, was approximately RMB 145.4 million, a decrease of about RMB 157.8 million or 52.0% compared to RMB 303.2 million for the same period in 2022[52]. - Basic earnings per share for the six months ended June 30, 2023, was RMB 4.06, down from RMB 8.54 in 2022, representing a decline of approximately 52.4%[80]. Research and Development - As of June 30, 2023, the group has 39 products under development in China, including 13 oncology products and 12 CNS products[4]. - The R&D team consists of 908 employees, including 79 PhDs and 447 Master's degree holders[3]. - The group holds 272 patents in China and 481 patents overseas, with additional patents pending[3]. - The group aims to continue investing in the strategic therapeutic areas of oncology, CNS, cardiovascular, and digestive and metabolic diseases[3]. - The company continues to invest in four strategic therapeutic areas: oncology, central nervous system, cardiovascular, and metabolic diseases, with 39 products in various stages of development in China as of June 30, 2023[23]. - LY03003, a long-acting injectable for Parkinson's disease, has its New Drug Application (NDA) accepted by the CDE in August 2023, marking it as the first global product to provide continuous dopamine stimulation[25]. - Bai Tuo Wei (Goserelin microspheres) is the first and only approved long-acting microsphere formulation globally, approved in June 2023 for prostate cancer treatment, and in September 2023 for breast cancer in premenopausal women[26]. - The innovative microsphere technology of Bai Tuo Wei significantly improves patient experience with a needle diameter of only 0.8 mm, enhancing the drug delivery process[26]. Market and Product Development - The group has established a national sales and distribution network covering over 21,660 hospitals across 31 provinces in China[3]. - The group has established a global supply chain with 8 production bases and a GMP quality management system[8]. - The group has over 30 domestic and more than 10 international products in the pipeline, focusing on innovative drug delivery technologies[8]. - The group’s major products in China include 4 oncology drugs, 3 central nervous system drugs, 3 cardiovascular drugs, and 1 metabolic drug[10]. - The company aims to maintain or steadily grow its market share in high-prevalence disease areas with its 12 major products[11]. - The flagship product Xuezhikang generated over RMB 1 billion in sales in 2021 and is expected to maintain double-digit growth in the coming years[38]. - The company plans to expand its sales team in core therapeutic areas and deepen its market coverage in oncology and central nervous system treatments[42]. Financial Position and Liabilities - The total assets as of June 30, 2023, amounted to RMB 26,300.2 million, while total liabilities were RMB 14,105.9 million[7]. - As of June 30, 2023, the group had total borrowings of approximately RMB 8,372.6 million, an increase from RMB 7,642.7 million as of December 31, 2022[54]. - The company reported a total of RMB 12,855,350,000 in financial liabilities as of June 30, 2023, including interest-bearing loans and borrowings of RMB 7,642,713,000[157]. - The company has secured bank loans with actual interest rates ranging from 2.80% to 5.00% due between 2023 and 2024, totaling RMB 3,388,117 thousand[132]. - The company has a total of RMB 379,664 thousand in other non-current liabilities as of June 30, 2023[136]. Shareholder Information and Corporate Governance - Major shareholders include Green Leaf Pharmaceutical Investment Limited, holding 1,257,196,703 shares (33.42%)[67]. - Hillhouse NEV Holdings Limited holds 552,324,108 shares, representing 14.68% of the company[67]. - UBS Group AG has a holding of 414,017,118 shares (11.01%) and 368,053,174 shares in short positions (9.78%)[67]. - The company has complied with all applicable corporate governance code provisions except for the separation of the roles of Chairman and CEO, which are held by the same individual[60]. - The company’s audit committee reviewed the unaudited interim financial statements for the six months ended June 30, 2023, and recommended their adoption to the board[63]. Cash Flow and Investments - Net cash flow from operating activities increased to RMB 689,727 thousand, up from RMB 604,447 thousand year-over-year, representing a growth of approximately 14.1%[89]. - Total cash and cash equivalents at the end of the period reached RMB 4,472,767 thousand, compared to RMB 3,372,826 thousand in the previous year, reflecting an increase of about 32.5%[90]. - Cash flow from investing activities showed a net outflow of RMB 78,019 thousand, a significant decrease from a net inflow of RMB 319,776 thousand in the prior year[89]. - The company reported a significant increase in interest expenses, totaling RMB 306,837 thousand, up from RMB 214,111 thousand, which is an increase of about 43.3%[88]. Related Party Transactions and Legal Matters - The group reported related party transactions totaling RMB 5,035,000 in product sales to Steward Cross and RMB 2,709,000 to Qingdao Luye for the six months ended June 30, 2023[142]. - The group has outstanding receivables from related parties amounting to RMB 24,673,000 as of June 30, 2023, with significant amounts due from Yantai Painuo (RMB 19,411,000) and Qingdao Luye (RMB 1,365,000)[144]. - The group has received approval to appeal a court decision regarding the arbitration ruling, with a hearing scheduled for the end of 2023[138]. Employee Incentives and Share Plans - The company adopted a share incentive plan on January 10, 2017, which is effective for ten years, aimed at rewarding employees and retaining talent[146]. - The share incentive plan was terminated early on January 20, 2023, due to the share price falling below HKD 4, resulting in all granted shares becoming void[148]. - The company confirmed zero expenses related to share-based payments during the reporting period, compared to RMB 6,966,000 for the six months ending June 30, 2022[150].
绿叶制药(02186) - 2023 - 中期业绩
2023-08-29 13:57
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性或完整性亦不 發表任何聲明,並明確表示,概不就因本公告之全部或任何部份內容而產生或因倚賴該等內容而引致之任何 損失承擔任何責任。 LUYE PHARMA GROUP LTD. 綠 葉 製 藥 集 團 有 限 公 司 ( 於百慕達註冊成立之有限公司) (股份代號:02186) 截至2023年6月30日止六個月之中期業績公告 | --- | --- | |-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | 財 | 務 摘 要 | | . | 收 入 較 截 至 2022 年 6 月 30 日 止 六 個 月 增 加 人 民 幣 53.3 百 萬 元 或 1.9% 至 人 民 幣 2,90 ...
绿叶制药(02186) - 2022 - 年度财报
2023-04-27 14:16
| | | | 公司概覽 | 02 | | --- | --- | | 公司資料 | 03 | | 財務摘要 | 05 | | 主席致辭 | 06 | | 管理層討論及分析 | 08 | | 董事及高級管理層 | 28 | | 董事會報告 | 35 | | 企業管治報告 | 52 | | 獨立核數師報告 | 66 | | 綜合損益表 | 71 | | 綜合全面收益表 | 72 | | 綜合財務狀況表 | 73 | | 綜合權益變動表 | 75 | | 綜合現金流量表 | 77 | | 財務報表附註 | 80 | 公司概覽 綠叶制药集团有限公司(「本公司」、「綠叶制药」,連同其附屬公司統稱為「本集團」)致力於在中華人民共和國(「中 國」或「中國內地」)、美利堅合眾國(「美國」)、歐洲及其他新興國家或地區四個規模最大及增長速度最快的治療領 域(即腫瘤科、中樞神經系統(「中樞神經系統」)、心血管系統及消化與代謝)進行創新藥品的開發、生產、推廣及 銷售。本集團的產品組合包括超過30種產品,覆蓋包括大型製藥市場中國、美國、歐洲及日本在內等全球80個以 上國家及地區以及快速發展的新興市場。 本集團已經建立一個龐大的全國性 ...
绿叶制药(02186) - 2022 - 年度业绩
2023-03-29 14:50
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性或完整性亦不 發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容而產生或因倚賴該等內容而引致之任何損 失承擔任何責任。 LUYE PHARMA GROUP LTD. 綠 葉 製 藥 集 團 有 限 公 司 ( 於百慕達註冊成立之有限公司) (股份代號:02186) 截至2022年12月31日止年度之年度業績公告 | --- | --- | |-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
绿叶制药(02186) - 2021 - 年度财报
2022-04-28 14:00
2021 年報 Luye Pharma Group Ltd. 綠葉制藥集團有限公司 (於百慕達註冊成立之有限公司) 股份代號:2186 Luye Pharma Group Ltd. 綠葉制藥集團有限公司 年報 ANNUAL REPORT 2021 www.luye.cn 綠葉制藥集團有限公司 | | | 02 公司概覽 03 公司資料 05 財務摘要 06 主席致辭 08 管理層討論及分析 26 董事及高級管理層 32 董事會報告 49 企業管治報告 60 獨立核數師報告 65 綜合損益表 66 綜合全面收益表 67 綜合財務狀況表 69 綜合權益變動表 71 綜合現金流量表 74 財務報表附註 公司概覽 本集團致力於在中華人民共和國(「中國」)、美利堅合眾國(「美國」)、歐洲、日本及其他新興國家或地區四個規模 最大及增長速度最快的治療領域(即腫瘤科、中樞神經系統(「中樞神經系統」)、心血管系統及消化與代謝)進行創 新藥品的開發、生產、推廣及銷售。本集團的產品組合包括超過30種產品,覆蓋包括大型製藥市場中國、美國、 歐洲及日本在內等全球80個以上國家及地區以及快速發展的新興市場。 本集團已經建立一個龐大的全國 ...