28 August 2025 | 12:32AM HKT Innovent Biologics (1801.HK): Earnings Review: Expect higher FY profit with 1H beat; first ph3 MRCT to accelerate IBI363 development Higher profit with deepening operating efficiency: 1H25 revenues of Rmb5.95bn (+51% y/y, vs. GSe Rmb5.94bn) were in-line, with 1) Rmb5.2bn of product sales (+37% y/y, as disclosed in early August, see our note) driven by the expanding commercial franchise (16 products in total), particularly the growing General Medicines portfolio, with the sales r ...

Summary of Innovent Biologics Conference Call Company Overview - **Company**: Innovent Biologics (1801.HK) - **Industry**: Biopharmaceuticals, focusing on immuno-oncology and metabolic diseases Key Financial Performance - **2Q25 Product Revenue**: Exceeded Rmb2.7 billion, representing a **35% year-over-year increase** and a **13% quarter-over-quarter increase** from Rmb2.4 billion in 1Q25 [1] - **Tyvyt Sales**: Reported at US$137 million in 2Q25, a **19% year-over-year increase**, but largely flat compared to previous quarters [1] - **New Product Launches**: Five new products launched in 2025, contributing to a **186% year-over-year increase** in sales from the new product portfolio, excluding Tyvyt and biosimilars [1] Market Position and Strategy - **Mazdutide**: Recently approved and launched, positioned favorably in the obesity market, especially amid NOVO's destocking in China [2] - **Pricing Advantage**: Mazdutide priced at approximately Rmb2,920 per month, offering a discount compared to competitors like Zepbound [2] - **Sales Growth Drivers**: Continued momentum expected in 1H25, driven by strong uptake in tafolecimab post NRDL inclusion and the anticipated sales uptake of mazdutide [1][2] Competitive Landscape - **NOVO's Ozempic Sales**: Experienced a **37% year-over-year decline** in 2Q25 due to destocking, creating an opportunity for mazdutide to capture market share [2] - **Market Dynamics**: The obesity market in China is seen as expanding due to limited competition and NOVO's passive strategy, which benefits Innovent's proactive promotion of mazdutide [2] Financial Projections and Valuation - **2025 Revenue Forecast**: Full-year product sales projected at Rmb11.7 billion, a **42% year-over-year increase** [1] - **Target Price**: Updated DCF-based 12-month target price set at HK$98.23, reflecting a **7.5% upside** from the current price of HK$91.40 [7][15] - **Earnings Estimates**: Adjusted EPS estimates for 2025-2027 reflect slight downward revisions due to near-term sales growth adjustments [7] Risks and Considerations - **Key Risks**: 1. Intensifying competition in the PD-1/L1 market in China [7][13] 2. Uncertain approval timelines for key candidates [7][13] 3. Potential restrictions on off-label use due to safety issues [7][13] 4. Risks associated with R&D project failures [7][13] Conclusion - Innovent Biologics is positioned to leverage its strong product pipeline and market dynamics to drive growth, particularly with the launch of mazdutide. The company is viewed as undervalued relative to its potential, with a favorable outlook for continued revenue growth in the coming years.

Core Insights - A leading Chinese drug developer, Jiangsu Hengrui Pharmaceuticals, is advancing in the weight-loss medication market with promising Phase Three trial results for its dual-acting obesity drug, HRS9531, which targets the same peptide receptors as Eli Lilly's tirzepatide [2][3][4] Company Developments - Hengrui Pharmaceuticals recently listed its shares in Hong Kong and has reported positive trial data for HRS9531, a dual-acting obesity drug [3][5] - The company plans to apply for domestic marketing approval for HRS9531 following successful Phase Three trial outcomes [4][6] - The trial involved 567 participants, with those receiving the drug achieving significant weight loss, including a mean weight loss of up to 17.7% and 88% of participants losing at least 5% of their weight [7][8] Market Context - The weight-loss medication market is highly competitive, with major players like Novo Nordisk and Eli Lilly leading the sector [12][17] - Hengrui Pharma's drug is positioned to compete with established products, as it targets GLP-1 and GIP receptors, similar to tirzepatide [10][15] - The market for weight-loss drugs in China is expanding rapidly, with over 200 pipelines currently in development [13] Financial Implications - Hengrui Pharma's stock has traded at a premium of approximately 10% over its Shanghai-listed shares, reflecting investor confidence in its potential [5] - The company has licensed rights to HRS9531 outside Greater China to Kailera Therapeutics, receiving $110 million in upfront payments and potential milestone payments totaling up to $5.725 billion based on sales [11] Competitive Landscape - The success of semaglutide has spurred a race for similar products, with Hengrui Pharma aiming to launch China's first independently developed GLP-1/GIP product [13][17] - Despite the dominance of established players, the high-growth market presents opportunities for new entrants like Hengrui Pharma [16][17]

Core Viewpoint - The injectable GLP-1/GIP dual agonist HRS9531 developed by Heng Rui Pharmaceutical has shown promising results in a 48-week Phase III clinical trial, achieving an average weight loss of nearly 18%, with plans to apply for market approval in China as soon as possible [2][6]. Group 1: Clinical Trial Results - The Phase III clinical study conducted in China evaluated doses of HRS9531 at 2 mg, 4 mg, and 6 mg weekly, involving 531 overweight or obese adults without diabetes, showing a maximum weight loss of 17.7%, with a placebo-adjusted weight loss of 16.3% [2]. - In a predefined supplementary analysis, the 6 mg dose group achieved a weight loss of 19.2% [2]. - Among participants receiving HRS9531, 88% achieved at least a 5% weight loss, and 44.4% achieved a weight loss of 20% or more, meeting the primary endpoint [3]. Group 2: Safety and Side Effects - Most adverse events reported were mild to moderate, primarily gastrointestinal reactions [3]. - The company emphasized the good safety and tolerability of HRS9531, suggesting its potential to help more obese patients achieve personalized weight loss goals [7]. Group 3: Competitive Landscape and Future Plans - HRS9531 is expected to compete with Eli Lilly's GLP-1/GIP dual agonist Tirzepatide (Zepbound), which previously demonstrated a 20.9% weight loss in a 36-week study [2]. - Kailera Therapeutics, Heng Rui's partner in the U.S., announced plans to explore higher doses and longer treatment durations in global clinical trials to expand the drug's potential [5][6]. - If approved, HRS9531 will be the second domestically approved weight loss drug following Innovent Biologics' dual agonist Mazdutide [6].

Group 1: IBI363 Development and Clinical Trials - IBI363 is positioned as a promising next-generation immuno-oncology (IO) therapy with Phase 3 trials underway, showing strong survival benefits and broad potential, especially for IO-resistant and cold tumors [1] - In squamous non-small cell lung cancer (sq-NSCLC), IBI363 (3mg/kg) achieved a median progression-free survival (mPFS) of 9.3 months, significantly outperforming docetaxel, which had mPFS of 3.9 months for sq- and 3.6 months for non-squamous NSCLC [1] - The 12-month overall survival (OS) rate for IBI363 reached 70.9% in sq-NSCLC and 71.6% in non-squamous NSCLC, surpassing the 65% OS rate reported for AK112 + docetaxel in IO-resistant NSCLC patients [1] Group 2: Future Trials and Market Potential - The pivotal Phase 2 trial in first-line melanoma is expected to complete enrollment by year-end, with Phase 3 trials set to begin in the second half of 2025, targeting IO-resistant sq-NSCLC and third-line MSS colorectal cancer [1] - Innovent anticipates releasing Phase 1b/2 proof-of-concept data for IBI363 in first-line NSCLC and MSS colorectal cancer in 2026, indicating broader market opportunities [1] - IBI363 also has potential for combination therapies with antibody-drug conjugates (ADCs) and out-licensing opportunities, enhancing its market positioning [1] Group 3: Innovent's Broader Pipeline - Innovent is developing a robust pipeline of next-generation IO agents and ADCs, including PD-1/IL-12, PD-L1/CD40, and multiple T-cell engagers (TCEs) targeting various cancer markers [1] - IBI3003, a TCE targeting GPRC5D/BCMA/CD3, has shown superior efficacy compared to existing therapies in preclinical models, indicating its potential to compete with CAR-T therapies [1] - Innovent is also advancing a diverse ADC pipeline, including monoclonal ADCs and bispecific ADCs, with promising signals observed in multiple tumor models [1] Group 4: Non-Oncology Innovations - Innovent launched mazdutide, China's first domestic dual-target GLP-1 drug for obesity, marking a significant milestone in its non-oncology portfolio [1] - Other non-oncology assets like IBI311 (for thyroid eye disease), IBI306 (for hypercholesterolemia), and IBI112 (for psoriasis) are expected to become important revenue drivers [1] - The company is advancing a strong early-stage cardiovascular medicine (CVM) pipeline and has several assets in clinical development for autoimmune diseases [1] Group 5: Financial Outlook - The company maintains a positive outlook on the global potential of its innovative pipelines and is on track to achieve EBITDA breakeven this year [2] - The successful development of IBI363 has led to an improved probability of success for the asset, prompting an increase in the discounted cash flow (DCF)-based target price to HK$102.95 from HK$94.74 [2]

Investment Rating - The investment rating for Innovent Biologics is "Buy" with a 12-month price target of HK$74.95, indicating a downside potential of 11.4% from the current price of HK$84.60 [9]. Core Insights - Innovent Biologics is focusing on a multi-channel strategy for the launch of mazdutide, targeting hospitals, offline healthcare providers, and online pharmacies to maximize market reach [5][6]. - The company aims to build a competitive barrier for mazdutide through its dual-target mechanism and plans for new indication expansions, including Type 2 Diabetes (T2D) approval expected in the second half of 2025 [6][8]. - Innovent is prioritizing the clinical development of IBI363, with plans to advance multiple indications into registrational trials and a preference for co-development with multinational corporations to enhance its global presence [8]. - The company's go-global strategy is viewed as a long-term process, with a commitment to invest in assets with global potential while maintaining profitability in the China market [8]. Summary by Sections Multi-Channel Coverage for Mazdutide - Innovent has initiated a multi-channel coverage strategy for mazdutide, with the first product batch shipped shortly after approval. The strategy includes targeting hospitals, offline healthcare providers, and online pharmacies [5]. - Management expressed confidence in market demand based on pre-launch feedback and sufficient supply preparation [5]. Competitive Landscape - The pricing strategy for mazdutide positions it at a premium compared to competitors, with a focus on dual-target differentiation and plans for expanding indications [6]. Maximizing Potential of IBI363 - IBI363 is a key focus for Innovent, with plans to advance three priority indications into registrational trials. The company emphasizes quick clinical progress and seeks co-development partnerships to maximize value [8]. Go-Global Strategy - Innovent's go-global strategy is a long-term approach, with plans to invest in assets with global potential while ensuring profitability in the domestic market [8].

Pharmaceutical Industry - China's homemade weight-loss drug mazdutide has been approved [1] - Doctors hope mazdutide will help more patients get treatment [1]