Innovent 2024 INTERIM REPORT 中期報告 信達生物製藥 Innovent Biologics, Inc. (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立之有限公司) Stock Code 股份代號:1801 | --- | --- | |------------------------------|-------| | 目錄 | | | 公司簡介 | 2 | | 公司資料 | 3 | | 財務摘要 | 5 | | 業務摘要 | 8 | | 管理層討論與分析 | 12 | | 其他資料 | 34 | | 簡明綜合財務報表審閱報告 | 57 | | 簡明綜合損益及其他全面收入表 | 58 | | 簡明綜合財務狀況表 | 59 | | 簡明綜合權益變動表 | 61 | | 簡明綜合現金流量表 | 62 | | 簡明綜合財務報表附註 | 64 | | 釋義 | 87 | 公司簡介 2 信達生物製藥 公司簡介概覽 信達生物製藥集團成立於2011年，以開發出老百姓用得起的 高質量生物藥為使命和目標，公司 ...

SAN FRANCISCO and SUZHOU, China, Sept. 26, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center f ...

SAN FRANCISCO and SUZHOU, China, Sept. 17, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that clinical data of IBI363 (first-in-class PD1/IL-2α-bias bispecific antibody fusion protein) combined with bevacizumab in advanced colorectal cancer is present ...

SAN FRANCISCO and SUZHOU, China, Sept. 11, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 clinical trial results for mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with ...

SAN FRANCISCO and SUZHOU, China, Sept. 10, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the presentation of Phase 1 clinical data (ClinicalTrials.gov, NCT04085185) for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in adva ...

Investment Rating - The report gives a "Buy" rating for the company with a target price of HKD 58.05 [5] Core Views - The company has a strong R&D engine and commercialization capabilities, aiming for RMB 20 billion in revenue by 2027 [1] - The company has 11 approved products, with product revenue reaching RMB 3.8 billion in H1 2024, a 55% YoY increase [1] - The company is focusing on four key disease areas: oncology, cardiovascular & metabolic, autoimmune, and ophthalmology, with a diversified product pipeline [1] - The company expects to have nearly 20 approved products by 2027, targeting RMB 20 billion in domestic revenue [1] Oncology - The company has 9 approved oncology products, with 1 NDA submitted and 2 in key clinical stages [2] - Sintilimab (PD-1) sales reached RMB 2.75 billion in 2023, a 34% YoY increase, and is expected to maintain growth due to its inclusion in the national reimbursement drug list (NRDL) [2] - The company is developing next-generation IO therapies, including a global first-in-class PD-1/IL-2 bispecific antibody (IBI363), which has shown promising efficacy in Phase I trials [2] - The company is leveraging its "IO+ADC" dual strengths, with IBI343 (CLDN18.2 ADC) showing potential as a best-in-class ADC in gastric and pancreatic cancers [34] Metabolic and Cardiovascular - Mazdutide (GLP-1R/GCGR dual agonist) is the first GLP-1R/GCGR dual agonist to enter Phase III globally, with NDAs submitted for obesity and type 2 diabetes [3] - Mazdutide has shown significant weight loss and glycemic control in clinical trials, with potential to become a leading treatment for obesity and diabetes [44] - Tafolecimab (PCSK9 inhibitor) is the first domestically developed PCSK9 monoclonal antibody approved in China, with potential for inclusion in the NRDL in 2024 [49] Autoimmune and Ophthalmology - The company has a strong pipeline in autoimmune diseases, including IBI112 (IL-23p19 inhibitor) for psoriasis, which has shown best-in-class potential with a 12-week dosing interval [3] - IBI311 (IGF-1R inhibitor) is expected to be the first innovative drug for thyroid eye disease (TED) in China, with NDA submitted [3] Financial Projections - The company is expected to achieve revenues of RMB 8 billion, RMB 11 billion, and RMB 14.7 billion in 2024, 2025, and 2026, respectively, with YoY growth rates of 29%, 37%, and 34% [3] - Net profit is projected to turn positive in 2025, reaching RMB 121 million, and further increase to RMB 1.34 billion in 2026 [3] - The company's DCF valuation suggests a fair value of HKD 58.05 per share, with a market cap of HKD 94.7 billion [3]

SAN FRANCISCO and SUZHOU, China, Sept. 9, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces an oral presentation of updated results from a pivotal Phase 2 clinical trial of Dupert®（fulzerasib）for the treatment of adult patients with advanced non-small cel ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HK$61.98, reflecting a potential upside of 42% from the current price of HK$43.50 [2][4][8]. Core Insights - The company is expected to achieve a revenue CAGR of approximately 30% from 2024 to 2026, driven by strong market demand for its products [2][3]. - The company reported a significant increase in product revenue for 1H24, reaching RMB 3.81 billion, a year-on-year growth of 55.1% [2][6]. - The gross margin for 1H24 was 84.1%, an increase of 1.8 percentage points compared to the previous year, attributed to rising sales and decreasing production costs [2][3]. - The company has multiple key products in the cardiovascular and metabolic (CVM) fields awaiting approval, which are considered crucial for future growth [2][3]. Financial Summary - The company's revenue is projected to grow from RMB 6,206 million in 2023 to RMB 12,948 million by 2026, with a gross profit increasing from RMB 5,070 million to RMB 10,667 million over the same period [1][12]. - The net profit is expected to turn positive by 2025, reaching RMB 1,004 million, and further increasing to RMB 2,508 million by 2026 [1][12]. - The earnings per share (EPS) is forecasted to improve from a loss of RMB 0.66 in 2023 to a profit of RMB 1.61 by 2026 [1][12]. Valuation Analysis - The report employs a two-stage DCF valuation method, resulting in a target price of HK$61.98, which corresponds to a 2025 enterprise value/revenue multiple of 7.7x, significantly higher than the comparable company average of 4.0x [8][9]. - The WACC used in the valuation is 10.2%, with a perpetual growth rate of 3% [8][9].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The report highlights strong growth in product sales and a significant narrowing of adjusted LBITDA. The total revenue for the first half of 2024 reached 39.52 billion CNY, representing a year-on-year increase of 46.3%, with product revenue at approximately 38.11 billion CNY, up 55.1% year-on-year. The company reported a loss of 3.93 billion CNY, compared to a loss of 1.39 billion CNY in the same period of 2023. Adjusted LBITDA was 1.61 billion CNY, down from 2.67 billion CNY in 2023, marking a 39.9% reduction in losses [3] Summary by Sections Financial Performance - In the first half of 2024, adjusted R&D expenses were 12.94 billion CNY, compared to 8.26 billion CNY in the same period of 2023. Adjusted selling expenses were 18.51 billion CNY, accounting for 46.8% of revenue, a decrease of 2.8 percentage points year-on-year. The adjusted gross margin was 84.1%, up from 82.3% in the same period of 2023, due to increased sales volume and improved production efficiency [3][4] Product Development - The company announced that its KRAS G12C inhibitor, Daberit®, received NMPA approval for use in adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations. This is the first KRAS G12C inhibitor approved in China and marks the company's 11th product [3] Future Growth Prospects - The company has a robust pipeline with 11 approved products and 3 new products in the NDA stage. Six additional product applications are currently under review. The company aims to commercialize 20 products by 2027, targeting sales revenue of 20 billion CNY [3][4] Profit Forecast - The company is projected to have a net profit of -6.05 billion CNY in 2024, followed by 3.04 billion CNY in 2025 and 10.22 billion CNY in 2026, with year-on-year growth rates of 41%, 150%, and 236% respectively. The long-term development outlook is positive, leading to the maintenance of the "Buy" rating [3][4]

Investment Rating - The report maintains an "Outperform" rating for Innovent Biologics with a target price adjusted to HKD 67.8 per share [9][17]. Core Insights - Innovent Biologics reported strong revenue growth in H1 2024, with total revenue reaching RMB 39.5 billion, a 46.3% increase year-on-year, and product revenue of RMB 38.1 billion, up 55.1% [3][14]. - The company's gross margin improved to 82.9%, reflecting operational efficiency enhancements, while R&D expenses increased by 51.6% to RMB 14.0 billion, accounting for 35.4% of revenue [3][14]. - The report highlights the successful sales performance of key products, including Tyvyt (PD-1 inhibitor) and several biosimilars, contributing to the revenue growth [4][14]. Financial Performance - For H1 2024, the company reported a net loss of RMB 3.9 billion, compared to a loss of RMB 1.4 billion in the same period last year [3][14]. - Adjusted LBITDA for the period was RMB 1.6 billion, a decrease of 39.9% from RMB 2.7 billion in the previous year [3][14]. - As of June 30, 2024, the company had cash and short-term financial assets totaling RMB 101.1 billion [3][14]. Product Pipeline and Growth Potential - The oncology pipeline is rich with catalysts, including the recent NMPA approval of Fulzerasib (KRAS G12C) and expected approval of IBI344 (ROS1) in H2 2024 [5][15]. - Upcoming clinical data updates for several early-stage products are anticipated, including IBI363 (PD-1/IL-2 α-bias) and IBI343 (CLDN18.2 ADC) [5][15]. - The non-oncology field is also progressing, with NDA submissions for Mazdutide (GLP-1R/GCGR) and Teprotumumab (IGF-1R) expected to bolster future revenue [5][16]. Revenue Forecast - Revenue forecasts for 2024-2026 have been adjusted to RMB 78.6 billion, RMB 102.5 billion, and RMB 133.9 billion, respectively, reflecting year-on-year growth rates of 26.7%, 30.3%, and 30.7% [9][17]. - The company is projected to achieve profitability by 2026, with a net profit attributable to shareholders of RMB 760 million [9][17].