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].

证券研究报告 | 半年报点评 gszqdatemark 2024 09 03 年 月 日 信达生物（01801.HK） 产品销售强劲增长，经调整 LBITDA 显著收窄 信达生物发布 2024 年中期业绩。公司 2024 年上半年总收入为 39.52 亿元，同比 +46.3%；其中产品收入约 38.11 亿元，同比+55.1%。期内亏损 3.93 亿元，2023 年 同期为亏损 1.39 亿元。经调整 LBITDA 为 1.61 亿元，2023 年同期为 2.67 亿元，同比 减亏 39.9%。 信达生物宣布 KRAS G12C 抑制剂达伯特®获得 NMPA 批准上市。达伯特®用于至少 接受过一种系统性治疗的 KRAS G12C 突变型的晚期非小细胞肺癌（NSCLC）成人患者， 是中国首个获批的 KRAS G12C 抑制剂，也是信达生物的第 11 款产品。 观点：产品销售强劲增长，经调整 LBITDA 显著收窄 收入端，信迪利单抗保持快速增长，新产品表现也比较强势，产品销售收入共 38.11 亿 元，同比增长 55.1%；期内亏损同比增加，主要由于非现金项目汇兑收益减少（绝对 额减少 2.13 亿元）、一次性 ...

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].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price raised to HKD 55.40 [3][4]. Core Insights - The company reported a strong sales performance in the first half of 2024, with a year-on-year revenue increase of 46.3% to RMB 3.95 billion, driven by a 55.1% increase in pharmaceutical sales [2][3]. - Despite a significant increase in net loss by 182.1% to RMB 390 million, this was attributed to the absence of a one-time tax refund from the previous year and an increase in R&D expenses [2]. - Revenue forecasts for 2024-2026 have been adjusted upwards, with a projected CAGR of 26.4% from 2023 to 2026 [3]. Summary by Sections Revenue and Profit Forecasts - The revenue forecast for 2024 has been slightly increased by 0.04%, with 2025 and 2026 revenue estimates raised by 4.4% and 5.9% respectively [3][6]. - The company expects a revenue CAGR of 26.4% from 2023 to 2026, driven by growth in existing and new products [3]. Product Pipeline - The core product, Dabu, continues to see increased indications, with a revenue increase of 45.6% in the first half of 2024, amounting to USD 239 million (approximately RMB 1.68 billion) [3]. - New products launched post-2020 have significantly contributed to revenue, with their share rising from 26.6% in 2021 to 58.8% in the first half of 2024 [3]. - The recently launched Dabot will contribute to revenue in the second half of the year, targeting a significant market in non-small cell lung cancer [3]. Financial Metrics - The company’s total revenue is projected to reach RMB 8.318 billion in 2024, RMB 10.437 billion in 2025, and RMB 12.538 billion in 2026, with respective growth rates of 34.0%, 25.5%, and 20.1% [7]. - The net loss is expected to decrease from RMB 729 million in 2024 to RMB 400 million in 2026, indicating a path towards profitability [7]. Valuation - The updated DCF model reflects an increase in the target price from HKD 51.05 to HKD 55.40, based on the upward revision of net profit forecasts for 2025-2026 [3][4].

Investment Rating - Maintain "Recommend" rating [1][3] Core Views - Revenue growth driven by strong demand for innovative product portfolio and effective commercialization strategy, with product revenue increasing by 55.1% YoY to 3.811 billion CNY [2] - Operating efficiency improved with product sales expense ratio decreasing by 5.9 percentage points and administrative expense ratio decreasing by 4.9 percentage points [2] - EBITDA loss narrowed by 39.9% to 160 million CNY, with potential to achieve EBITDA breakeven next year [2] - Solid foundation in oncology with PD-1 approved for seven indications and included in the national reimbursement drug list [2] - CVM pipeline commercialization expected to materialize soon, with 11 commercialized products and expanding reimbursement coverage [2] - Early-stage pipeline is rich with multiple innovative molecules showing positive data, including IBI363, IBI343, and IBI389 [3] - Revenue forecasts for 2024-2026 are 8.133 billion, 10.867 billion, and 13.595 billion CNY, with net profit turning positive in 2025 [3][5] Financial Performance - 2024 H1 revenue reached 3.952 billion CNY, a 46.3% YoY increase [2] - R&D investment in 2024 H1 was 1.294 billion CNY, with cash on hand at 10.112 billion CNY [2] - Gross margin expected to remain stable at 80.76% in 2024, increasing to 85.22% by 2026 [5][6] - Net profit forecasted to turn positive in 2025 at 53 million CNY, with significant growth to 818 million CNY in 2026 [5][6] Pipeline and Commercialization - Oncology: PD-1 remains a cornerstone product with seven approved indications, and new drugs like Tareltinib (ROS1) expected to be approved soon [2] - CVM: Masdutide for weight loss and type 2 diabetes, and Teprotumumab for thyroid eye disease have submitted NDAs [2] - Autoimmune: Piconibart (IL-23p19) plans to submit NDA within the year [2] - Early-stage pipeline includes IBI363 (PD-1/IL-2a), IBI343 (CLDN18.2 ADC), and IBI389 (CLDN18.2/CD3) showing promising results in clinical trials [3]

Investment Rating - Buy (Maintained) [1] Core Views - The company's revenue is expected to grow rapidly, with projected revenues of 7.9 billion, 10.3 billion, and 13.2 billion RMB for 2024, 2025, and 2026 respectively [4] - The company's net profit is forecasted to turn positive in 2025, reaching 436.85 million RMB, and further increasing to 1.16 billion RMB in 2026 [1] - The company's EPS is expected to improve significantly, from -0.37 in 2024 to 0.27 in 2025 and 0.71 in 2026 [1] Financial Performance - In the first half of 2024, the company achieved revenue of 3.95 billion RMB, a 46.3% year-on-year increase [2] - The company reported a net loss of 390 million RMB in the first half of 2024, with product revenue reaching 3.81 billion RMB, a 55.1% increase [2] - The company's revenue growth is driven by the strong performance of Tyvyt® (sintilimab injection) and other products, as well as the accelerated growth of new products [2] Product Pipeline - The company has launched one new innovative drug, expanding its commercialized products to 11 [3] - Six NDAs are under review by the NMPA, including IBI344 (taletrectinib, ROS1) for first-line and second-line indications, and IBI362 (mazdutide) for weight management and type 2 diabetes [3] - IBI344 (taletrectinib) is expected to be approved in the second half of 2024, and IBI112 (IL-23p19) is expected to submit an NDA [4] Key Data Updates - The company will present updated Phase 1 data for its global first-in-class PD-1/IL-2α-bias in lung cancer treatment at WCLC [4] - Key clinical data for IBI354 (HER2 ADC) in HER2-positive solid tumors will be presented at ESMO [4] - Multiple clinical data updates for Tyvyt® (sintilimab injection) are expected at upcoming conferences [4] Financial Metrics - The company's revenue growth rate is projected to be 27.34% in 2024, 30.87% in 2025, and 28.06% in 2026 [1] - The company's net profit growth rate is expected to be 171.51% in 2025 and 166.12% in 2026 [1] - The company's ROE is forecasted to improve from -5.13% in 2024 to 3.54% in 2025 and 8.60% in 2026 [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 60 [2][4]. Core Insights - The company's revenue for 1H24 reached RMB 39.5 billion, representing a year-on-year increase of 46.3% and a quarter-on-quarter increase of 12.8%. Product revenue specifically was RMB 38.1 billion, up 55.1% year-on-year and 16.5% quarter-on-quarter, aligning with previous announcements [3]. - The adjusted non-IFRS net loss for 1H24 was RMB 1.6 billion, a reduction of 15.9% year-on-year and 50.6% quarter-on-quarter, which was better than both the report's and market's expectations [3]. - The strong growth in product revenue is attributed to the robust performance of Tyvyt and three biosimilars, as well as the successful launch of new products like Sapitinib and Huiranzhuo [3]. - The company aims for EBITDA breakeven by 2025 and projects a revenue target of RMB 20 billion by 2027, with an expected revenue growth of approximately 30% in the second half of 2024 [3]. Financial Performance Summary - For 2022, the company reported revenue of RMB 4.56 billion, which increased to RMB 6.21 billion in 2023, and is projected to reach RMB 8.58 billion in 2024, reflecting a year-on-year growth of 36.2% [7]. - The adjusted net loss is expected to narrow from RMB 515 million in 2023 to RMB 328 million in 2024, with a return to profitability projected in 2025 with a net profit of RMB 1.7 billion [7]. - The gross margin is expected to improve to 83.0% by 2024, up from 81.7% in 2023 [9]. Research and Development Pipeline - The company is advancing its R&D pipeline, with key updates expected at upcoming conferences regarding IBI363 and other assets [3]. - The management has indicated that the sales efficiency of the oncology pipeline will improve, leading to a decrease in sales and administrative expenses in the second half of 2024 and beyond [3].