SAN FRANCISCO and SUZHOU, China, Sept. 1, 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 multiple clinical study results of mazdutide (GLP1R/GCGR dual agonist) will be presented at the European Association for the Study of Diabetes® (EASD) 60th An ...

Investment Rating - The report maintains an "Accumulate" rating for the company [2][4]. Core Viewpoints - The company achieved a strong revenue growth of 39.52 billion RMB in H1 2024, representing a 46.3% increase, slightly exceeding expectations [4]. - The forecast for revenue from 2024 to 2026 has been adjusted to 80.73 billion, 105.14 billion, and 131.75 billion RMB respectively, up from previous estimates [4]. - The company is expected to reach EBITDA breakeven by 2025, driven by the rapid commercialization of innovative products [4]. - The product revenue saw a significant increase of 55.1% in H1 2024, with key products like Sintilimab generating 2.40 billion USD in revenue [4]. - The company has a strong cash position of 101.12 billion RMB, ensuring long-term development [4]. Financial Summary - Revenue for 2021A was 4,270 million RMB, increasing to 6,206 million RMB in 2023A, with a projected growth to 8,073 million RMB in 2024E [1]. - Net profit improved from a loss of 3,138 million RMB in 2021A to a projected loss of 624 million RMB in 2024E, with a return to profitability expected in 2025E [1]. - The adjusted gross margin for H1 2024 was 84.1%, reflecting a 1.8 percentage point increase [4].

Investment Rating - The investment rating for the company is "Buy" with a target price raised to HKD 60.00, indicating a potential upside of 36.0% from the current price of HKD 44.10 [3][5]. Core Insights - The company reported a better-than-expected adjusted net loss in 1H24, with strong product sales growth and improved operational efficiency. Total revenue increased by 46% year-on-year to RMB 39.5 billion, driven by a 50% increase in PD-1 sales to over RMB 1.7 billion and a growing portfolio of biosimilar products [1][2]. - The company expects to achieve EBITDA breakeven by 2025, with a cash reserve of RMB 10.1 billion as of the end of 1H24. The guidance for product revenue is set to reach RMB 20 billion by 2027, supported by at least seven products expected to launch between 2H24 and 2027 [1][2]. Summary by Sections Financial Performance - In 1H24, the adjusted gross margin improved by 1.8 percentage points, while adjusted selling and administrative expenses decreased by 5.9 and 4.9 percentage points, respectively. The adjusted net loss narrowed to RMB 160 million from RMB 190 million in 1H23, outperforming market expectations [1]. - The company anticipates a 57% increase in R&D expenses for the year, with total R&D spending expected to be nearly USD 400 million [1]. Pipeline Strategy - The company maintains a clear pipeline strategy with a focus on oncology, utilizing an "IO+ADC" approach. The lifecycle management of PD-1 will explore major indications such as colorectal cancer and perioperative lung cancer. The next-generation IO candidate IBI363 has shown promising preliminary data [2]. - The company plans to launch the weight loss and diabetes indication for its product Masitide in 2025, with several other products also expected to be approved in the coming years [2]. Financial Projections - Revenue projections for 2024-2026 have been raised by 2-8%, with expected revenues of RMB 8.06 billion in 2024, RMB 10.94 billion in 2025, and RMB 13.20 billion in 2026 [7]. - The DCF valuation model estimates a share value of HKD 60.00, based on projected free cash flows and a perpetual growth rate of 2% [4].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% within the next 6-12 months [3][7]. Core Insights - The company reported a strong revenue growth of 55% year-on-year in 1H24, driven by the success of its commercial products, particularly the drug Dabrushe (Sintilimab) [2][3]. - The gross margin improved by 1.6 percentage points to 82.9%, attributed to increased production and ongoing cost optimization [3]. - The company is expanding its commercial product offerings, with expectations to increase the number of commercialized products to 12 by the end of the year [3]. Financial Summary - **Revenue Growth**: The company’s revenue is projected to grow from 6,206 million RMB in 2023 to 7,823 million RMB in 2024, reflecting a growth rate of 26.05% [1]. - **Net Profit**: The net profit is expected to improve significantly, moving from a loss of 1,028 million RMB in 2023 to a loss of 524 million RMB in 2024, with a forecasted profit of 1,098 million RMB by 2026 [1]. - **Earnings Per Share (EPS)**: The diluted EPS is projected to improve from -0.63 RMB in 2023 to 0.09 RMB in 2025, and further to 0.67 RMB in 2026 [1]. - **Return on Equity (ROE)**: The ROE is expected to turn positive by 2025, reaching 1.23% and further increasing to 8.29% by 2026 [1]. Research and Development - The company has six New Drug Applications (NDAs) currently under review by the National Medical Products Administration, with significant advancements in the cardiovascular and metabolic (CVM) fields [3]. - The company has multiple late-stage clinical projects making milestone progress, with several innovative pipelines showing promising preliminary data [3].

SAN FRANCISCO and SUZHOU, China, Aug. 28, 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 that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) ...

Core Viewpoint - Innovent Biologics reported strong commercial performance and significant pipeline milestones in the first half of 2024, indicating sustained growth and innovation in its operations [2][3]. Financial Performance - Total revenue reached RMB3,952.3 million, reflecting a year-over-year growth of 46.3% [3]. - EBITDA loss was reduced to RMB160.8 million, a notable year-over-year decrease of 39.9% [3]. - Gross profit margin improved to 84.1%, up by 1.8 percentage points year-over-year [3]. - Selling and marketing expenses decreased to 48.6%, down by 5.9 percentage points year-over-year [3]. - R&D expenses totaled RMB1,293.9 million, with cash and short-term financial assets amounting to RMB10,112.3 million (over USD1.4 billion) [3]. Product Revenue Growth - Product sales revenue was RMB3,811.4 million, showing a strong year-over-year growth of 55.1% [4]. - The company has eleven approved products, including TYVYT® and BYVASDA®, with new approvals in the Macau market [4]. - TYVYT® and BYVASDA® were included in the National Reimbursement Drug List (NRDL) for treating EGFR-mutated NSCLC [4][12]. Pipeline and Innovation - Seven new assets are in NDA review or pivotal registrational clinical trials, with 18 assets in early-phase clinical studies [6]. - Significant progress in late-stage assets, including new indications for TYVYT® and IBI310 [6]. - The company is actively preparing for commercialization in the cardiovascular and metabolic (CVM) field, with three new drug applications submitted [5]. Manufacturing and R&D Capacity - A new R&D center in Shanghai became operational in August 2024, enhancing research capabilities [7]. - The first manufacturing site has a production capacity of 60,000L for antibodies and ADCs, with a second site under construction [7]. ESG Commitment - Innovent is committed to sustainable development and ethical business practices, recently launching an ESG website to highlight its initiatives [7]. - The company received an 'A' level in MSCI ESG rating, positioning it at the forefront of the biotechnology industry [7].

Financial Performance - For the six months ended June 30, 2024, total revenue was RMB 3,952.3 million, an increase of 46.3% compared to RMB 2,701.5 million for the same period in 2023[3]. - Product revenue for the same period was RMB 3,811.4 million, representing a growth of 55.1% from RMB 2,457.5 million in the prior year[3]. - Gross profit for the six months ended June 30, 2024, was RMB 3,274.7 million, compared to RMB 2,196.9 million in the same period of 2023, representing a growth of 49%[40]. - The company reported a pre-tax loss of RMB 392.6 million for the six months ended June 30, 2024, compared to a loss of RMB 256.1 million in the same period of 2023[40]. - The net loss for the period was RMB 392.6 million, an increase of RMB 253.5 million from RMB 139.1 million in the prior year[3]. - The company’s basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.24, compared to RMB 0.09 in the same period of 2023[72]. - Other income increased to RMB 300.6 million for the six months ended June 30, 2024, from RMB 232.4 million in the same period of 2023, marking a rise of 29.3%[44]. Research and Development - Research and development expenses increased to RMB 1,399.4 million, compared to RMB 922.8 million in the same period last year[3]. - The company delivered six molecules into clinical research for new drug applications (IND) during the reporting period, enhancing global innovation and sustainable growth[9]. - IBI362 has five ongoing Phase 3 clinical trials, with GLORY-1 and DREAMS-1 achieving study endpoints to support its NDAs[7]. - The company is focused on developing innovative therapies for chronic diseases, with IBI3016 (AGT siRNA) entering Phase 1 clinical trials for hypertension[19]. - The company is actively expanding its pipeline with next-generation innovations, including bispecific antibodies and ADCs, targeting unmet needs in oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology[36]. Product Development and Approvals - The company expanded its commercial product portfolio to 11 products, including the approval of the KRAS G12C inhibitor Daberet® for treating advanced NSCLC patients with KRAS G12C mutations[6]. - The NDA for IBI311 (anti-IGF-1R monoclonal antibody) was submitted and accepted by NMPA in May 2024, addressing a significant unmet need in the TED field in China[17]. - The NDA for IBI344 (Tazemetostat) was accepted by NMPA for patients with locally advanced or metastatic ROS1-positive NSCLC, with approval expected in 2024[29]. - IBI343, a novel CLDN18.2 antibody-drug conjugate, showed positive Phase 1 clinical results for gastric cancer treatment and received breakthrough therapy designation from NMPA[8]. - The company aims to expand its product portfolio to 12 by the end of 2024, including two targeted therapies for NSCLC expected to be approved in the second half of the year[12]. Marketing and Sales - Sales and marketing expenses were RMB 1,879.4 million, accounting for 47.6% of total revenue, down from 49.9% in the previous year[3]. - The company is enhancing its marketing output and operational efficiency through resource allocation and effective management methods[13]. - The company is committed to creating sustainable shareholder value through its strong commercialization and R&D capabilities, as well as a promising late-stage pipeline[20]. Corporate Governance and Compliance - The company has complied with all applicable provisions of the Corporate Governance Code, except for the separation of the roles of Chairman and CEO, which are currently held by the same individual[63]. - The company established a strategic clinical trial collaboration with ImmVirX Pty Limited to evaluate the combination therapy of its drug with ImmVirX's experimental oncolytic virus[39]. - The company will continue to review and monitor its corporate governance practices to ensure compliance and maintain high standards[63]. Financial Position and Assets - As of June 30, 2024, the company had cash and cash equivalents, structured products, and other financial assets totaling approximately RMB 10.112 billion[14]. - Total current assets as of June 30, 2024, were RMB 13,427.9 million, an increase from RMB 11,048.7 million as of December 31, 2023[54]. - Total liabilities as of June 30, 2024, were RMB 8,099.8 million, compared to RMB 7,869.3 million as of December 31, 2023[54]. - The company had unused long-term bank loan facilities of approximately RMB 2,080.5 million as of June 30, 2024[55]. Employee and Operational Metrics - As of June 30, 2024, the company had a total of 5,263 employees, an increase from 4,872 employees as of December 31, 2023, with over 1,000 in R&D and over 3,000 in sales and marketing[61]. - The total salary cost for the six months ended June 30, 2024, was RMB 1,391.6 million, compared to RMB 1,358.8 million for the same period in 2023, reflecting an increase of approximately 2.4%[61]. - There were no significant labor disputes or recruitment difficulties encountered by the company during the reporting period[61].

Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for Dupert® (fulzerasib), the first KRAS G12C inhibitor in China, aimed at treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have undergone at least one systemic therapy [1][2] - The approval is based on a Phase 2 clinical study showing a confirmed objective response rate (ORR) of 49.1% and a disease control rate (DCR) of 90.5% among 116 evaluable NSCLC subjects [1][2] - Innovent has launched a total of 11 products and continues to expand its oncology portfolio, with Dupert® marking a significant advancement in targeted therapy for KRAS mutations [1][3] Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, cardiovascular, metabolic, autoimmune, and ophthalmic conditions [3] - The company has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials, and 18 molecules in early clinical stages [3] - Innovent collaborates with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [3] Product Details - Fulzerasib is designed to target the KRAS G12C mutation, which is prevalent in various cancers, including 15-20% of lung cancer cases [2] - The drug has shown promising preclinical results, demonstrating high selectivity towards the G12C mutation and effectively inhibiting downstream signaling pathways to induce tumor cell apoptosis [2] - The approval process for fulzerasib included Breakthrough Therapy Designation (BTD) from the NMPA for both advanced NSCLC and colorectal cancer patients with KRAS G12C mutations [2]

Investment Rating - The investment rating for the company is "Buy (Maintain)" [6] Core Insights - The company is a rare platform-type innovative drug enterprise in China, possessing top-tier capabilities in early drug discovery, clinical development, manufacturing, and commercialization. The rich pipeline of innovative drugs and the stable cash flow from 10 already marketed products provide a solid foundation for growth. Upcoming products like Masitide and Pikanqi monoclonal antibody have submitted applications for market approval, offering a second growth curve. Early pipelines such as PD-1/IL-2 bispecific antibodies show best-in-class potential and are expected to lead to significant overseas licensing deals [9][13][51]. Summary by Sections Company Overview - The company has transformed from an innovative biotech firm to a leading biopharmaceutical company in China, focusing on developing, manufacturing, and selling innovative drugs for major diseases such as cancer, metabolic disorders, autoimmune diseases, and ophthalmology. As of December 31, 2023, the company has approximately 6,000 employees and 26 clinical pipelines, with 10 innovative drug products already commercialized [20]. Market Potential - The market for anti-tumor drugs is rapidly growing, driven by an increasing number of cancer patients and unmet clinical needs. In 2022, there were 4.8247 million new cancer cases in China, and the anti-tumor drug market is projected to reach 586.6 billion yuan by 2030, with a CAGR of 12.4%. The obesity market is also expanding, with the obesity rate expected to rise from 50.7% in 2020 to 65.3% by 2035, leading to significant medical expenditures [10][37][40]. Product Pipeline and Commercialization - The company achieved product sales revenue of 5.728 billion yuan in 2023, a year-on-year increase of 38.4%. It has four new indications approved and four new drug applications submitted, with ten products entering Phase III or critical clinical stages. The company aims to commercialize about 20 innovative drug products by 2027, targeting annual domestic sales of 20 billion yuan [10][11][16]. Financial Forecast and Valuation - Revenue forecasts for 2024-2026 are 7.8444 billion yuan, 10.1333 billion yuan, and 13.2353 billion yuan, with year-on-year growth rates of 26.4%, 29.2%, and 30.6%, respectively. The net profit attributable to the parent company is expected to be -533.16 million yuan, 251.58 million yuan, and 1.33381 billion yuan, with growth rates of 48.13%, 147.19%, and 430.17% [11][15]. Competitive Advantages - The company has established a comprehensive and integrated technology platform for drug development, with a strong focus on R&D investment. The R&D expenses increased from 1.222 billion yuan in 2018 to 2.228 billion yuan in 2023, and the R&D team expanded from 492 to nearly 1,500 members [24][25]. The company has also formed strategic partnerships with major international pharmaceutical companies, enhancing its development capabilities [30]. Conclusion - The company is well-positioned for sustained growth due to its innovative drug pipeline, strong market potential in oncology and obesity, and robust financial forecasts. The ongoing commercialization of new products and the potential for significant licensing deals further enhance its investment appeal [9][10][11][51].

Core Insights - Innovent Biologics has announced a strategic partnership with WeComput to enhance its Artificial Intelligence for Drug Discovery platform, aiming to accelerate drug discovery and development processes using AI technology [1][2]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for oncology, cardiovascular, metabolic, autoimmune, and ophthalmology diseases. The company has launched 10 products and has multiple assets in various stages of clinical trials [4]. - WeComput specializes in computational technology for innovative drug research and development, integrating AI, biophysics, and high-performance computing to create a digital platform for drug molecule generation and design [6]. Partnership Details - The collaboration will leverage WeComput's WeMol molecular design platform to enhance Innovent's computing infrastructure, thereby improving computational efficiency and accelerating drug R&D [2]. - The partnership aims to create a comprehensive AI-driven drug discovery system that is efficient, user-friendly, and automated, which will help reduce costs and shorten the drug R&D cycle [2]. Industry Impact - The integration of AI technology is expected to inject new momentum into the pharmaceutical and biotech industries, enhancing R&D capabilities and expediting the development of innovative drugs [3]. - This collaboration is anticipated to foster the widespread application of AI in the biopharmaceutical sector, driving innovation and development within the global pharmaceutical industry [3].