云顶新耀(01952) - 2025 - 中期财报

Company Information This section provides essential corporate details, including governance, key personnel, and identifying information Company Basic Information This section provides an overview of Everest Medicines' fundamental details, including governance, key personnel, and corporate identifiers - Joint Company Secretary Ms. Liu Xuxin resigned on April 15, 2025, with Mr. Yang Jinghang appointed concurrently[4] - The company's auditor is Ernst & Young[4] - The company's stock code is 1952, and its website is **www.everestmedicines.com**[5](index=5&type=chunk) Business Summary This section highlights the company's strategic advancements, significant sales growth, and pipeline progress across key therapeutic areas Overall Business Overview The company significantly grew sales revenue and advanced its innovative pipeline by deepening its "dual-driver" strategy and strengthening its Asian market presence - The company deepened its "dual-driver" strategy, achieving significant sales revenue growth and smooth progress in its innovative product pipeline[6] - Three commercialized products cover kidney, infectious, and autoimmune diseases, with estimated combined peak sales revenue exceeding RMB 10 billion[6] - Nefecon® is included in the NRDL and received full NMPA approval, leading to rapid sales growth[6] Renal Pipeline Nefecon®, a key product for IgA nephropathy, received full NMPA approval and NRDL inclusion, enhancing patient access, while EVER001 showed positive efficacy and safety in its Phase 1b/2a trial for primary membranous nephropathy - Nefecon® implemented new medical insurance pricing in January 2025, enhancing patient accessibility[8] - In May 2025, Nefecon® received full NMPA approval, removing proteinuria restrictions and becoming the first and only fully approved causal treatment for IgA nephropathy[9] - EVER001 (sibrotuzumab) Phase 1b/2a trial showed anti-PLA2R autoantibody reduction of approximately 93% at 24 weeks, significant proteinuria decrease, stable renal function, and good safety[12] - Nefecon® production expansion approval will boost capacity to meet growing clinical demand in China and Asia more efficiently[13] Infectious Disease Pipeline The in vitro susceptibility testing standard for Eravacycline (Yijia®) was published, guiding clinical use, while EVER001's Phase 1b/2a trial reaffirmed positive efficacy and safety in primary membranous nephropathy - In June 2025, the "Eravacycline In Vitro Drug Susceptibility Testing Guidelines (2025)" were published, standardizing testing and interpretation[15] - EVER001 Phase 1b/2a interim data showed anti-PLA2R autoantibody reduction maintained above 93%, proteinuria levels decreased to 76.7% and 80.6% at 36 weeks, and high immunological complete remission rates[16] Autoimmune Disease Pipeline Etrasimod for ulcerative colitis demonstrated long-term safety and significant clinical benefits in global 4-year follow-up and Asian Phase III studies, gaining approval in Hong Kong, acceptance in Korea and Taiwan, and initiating local production - Etrasimod's global 4-year safety follow-up data confirmed good long-term safety and tolerability[19] - Etrasimod's Asian multi-center Phase III study showed significant clinical and endoscopic benefits, with consistent safety profiles[20] - Etrasimod Jiaxing factory production project launched, with an estimated annual capacity of 50 million tablets upon operation[20] - In April 2025, Etrasimod received formal marketing approval from the Hong Kong Department of Health, China[20] - Etrasimod was strongly recommended in the "2025 ACG Clinical Guidelines: Adult Ulcerative Colitis" for moderate to severe active UC induction and maintenance[20] mRNA Technology Platform The company established a leading AI+mRNA platform, advancing mRNA therapeutic cancer vaccines and self-generating CAR-T projects, with EVM16 in clinical trials, EVM14 gaining US FDA IND approval and China NMPA acceptance, and the CAR-T platform showing preclinical efficacy - The company developed an AI-driven "Miaosuan" neoantigen algorithm, advancing mRNA therapeutic cancer vaccines and self-generating CAR-T platforms[21] - Personalized therapeutic cancer vaccine EVM16 completed first patient dosing and has dosed nine patients at Peking University Cancer Hospital[7][23] - Universal therapeutic cancer vaccine EVM14 IND application received US FDA approval and China NMPA acceptance, with clinical sample production completed[7][23] - The self-generating CAR-T platform was validated in humanized mouse and non-human primate models, offering off-the-shelf, lymphodepletion-free, and dose-controllable advantages[21] Corporate Development The company removed its 'B' share designation, reflecting enhanced R&D and commercialization, successfully raised approximately HKD 1.55 billion for pipeline and commercialization acceleration, and became I-Mab's largest shareholder with a 16.1% stake, deepening its oncology immunotherapy strategy - In April 2025, the "B" designation was removed from Everest Medicines' stock short name, reflecting enhanced R&D, commercialization, and overall business fundamentals[28] - In July 2025, the company raised approximately HKD 1.55 billion through a placing of 22,561,000 shares, with several times oversubscription[28] - In August 2025, the company strategically increased its stake in I-Mab to approximately 16.1%, becoming its largest shareholder[28] Financial Highlights This section presents key financial performance indicators, including revenue growth, margin changes, and adjusted loss, based on IFRS and non-IFRS measures IFRS Figures For the six months ended June 30, 2025, revenue significantly increased by 48.0% to RMB 446.1 million, driven by Nefecon® and Yijia® growth, while gross margin decreased due to Nefecon®'s NRDL price adjustment, R&D expenses were optimized, and distribution and selling expenses rose with market expansion 2025 H1 Key Financial Data (IFRS) | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 446.1 | 301.5 | 48.0% | | Gross Margin | 67.1% | 76.6% | -9.5% | | Gross Margin (excl. intangible asset amortization) | 76.4% | 83.0% | -6.6% | | R&D Expenses | 195.2 | 253.2 | -22.9% | | G&A Expenses | 110.8 | 87.0 | 27.4% | | Distribution and Selling Expenses | 314.7 | 200.4 | 57.0% | - Revenue growth was primarily driven by the sustained growth of Nefecon® and Yijia® in commercialized markets[30] - Gross margin decreased primarily due to Nefecon®'s NRDL price reduction in mainland China and optimized product costs[32] Non-IFRS Measures For the six months ended June 30, 2025, adjusted loss significantly narrowed to RMB 146.9 million, and loss for the period substantially decreased to RMB 249.8 million, driven by strong product sales, improved operational efficiency, and the one-time impact of mRNA COVID-19 vaccine-related intangible asset impairment loss in the prior year 2025 H1 Non-IFRS Key Financial Data | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | YoY Change (RMB million) | | :--- | :--- | :--- | :--- | | Adjusted Loss for the Period | (146.9) | (212.6) | 65.7 (narrowed) | | Loss for the Period | (249.8) | (632.4) | 382.6 (decreased) | - Total operating expenses as a percentage of sales decreased by 40.1 percentage points, reflecting improved business and operational efficiency and focused resource allocation[36] - As of June 30, 2025, cash and cash equivalents and bank deposits totaled RMB 1,585.9 million[36] Management Discussion and Analysis This section provides a comprehensive review of the company's operational performance, product pipeline, commercialization strategies, and financial results for the period Overview As an integrated biopharmaceutical company, the company made significant progress in H1, including the removal of its 'B' share designation and a successful HKD 1.55 billion equity placement, bolstering capital reserves for its "dual-driver" strategy - The company is committed to creating value through a differentiated innovative medicine portfolio and building sustainable shareholder growth[41] - The "dual-driver" strategy focuses on organic pipeline growth via mRNA technology and synergistic effects through business expansion and in-licensing[41] - Nefecon®'s full-year sales are projected to reach RMB 1.2 to 1.4 billion, with total company full-year revenue expected to be RMB 1.6 to 1.8 billion[39][40] Product Pipeline The company boasts a robust pipeline in renal, anti-infective, and autoimmune diseases, featuring first-in-class or best-in-class assets like approved Nefecon®, Yijia®, and Etrasimod, alongside clinical-stage candidates and advanced mRNA platform projects - The company's product pipeline includes first-in-class or best-in-class assets across renal, anti-infective, and autoimmune disease areas[43] Key Product Pipeline and Development Status | Molecule (Therapy) | Partner | Commercial Rights | Indication | R&D Progress | | :--- | :--- | :--- | :--- | :--- | | NEFECON® | Greater China, Singapore, South Korea | IgA Nephropathy | Approved in Mainland China, Macau, Hong Kong, Taiwan, South Korea, and Singapore | | Yijia® (Eravacycline) | Greater China, South Korea, Southeast Asia | Complicated Intra-abdominal Infections | Approved in Mainland China, Hong Kong, Taiwan, and Singapore | | Etrasimod | Greater China, South Korea, Singapore | Ulcerative Colitis | Approved in Macau, Hong Kong, and Singapore | | Cefepime-Taniborbactam | Greater China, South Korea, Southeast Asia | Complicated Urinary Tract Infections | Priority Review in Mainland China | | Zetomipzomib | Greater China, South Korea, Southeast Asia | Autoimmune Hepatitis | Phase 2a | | EVER001 (XNW1011) | Global | Membranous Nephropathy | Phase 1b/2a | | Personalized Cancer Vaccine | In-house R&D | Global | Oncology | IIT initiated | | Tumor-Associated Antigen Vaccine | In-house R&D | Global | Oncology | US IND approved | Business Review This section reviews pipeline and commercialization progress, highlighting Nefecon®'s full approval across Asia, Etrasimod's Hong Kong approval and regulatory submissions, positive EVER001 Phase 1b/2a data, and significant advancements in proprietary mRNA cancer vaccines EVM16 and EVM14, with EVM14 achieving dual US and China filings - Nefecon® achieved full approval across all authorized regions, solidifying its cornerstone position as a first-line treatment for IgA nephropathy in Asia[46] - Etrasimod received new drug marketing approval in Hong Kong SAR, with applications accepted in South Korea and Taiwan, and NMPA approval in mainland China expected in H1 2026[46] - EVER001 Phase 1b/2a trial for primary membranous nephropathy showed positive data, with anti-PLA2R antibody levels decreasing by nearly 100% and proteinuria levels by approximately 80%[47] - Personalized mRNA cancer vaccine EVM16 IIT completed dosing for 9 patients, with preliminary data expected in H2 this year[48] - Universal TAA mRNA vaccine candidate EVM14 received US FDA IND approval and China NMPA acceptance, achieving dual US and China filings[48] Pipeline Outlook Nefecon® achieved full approval across Asia, solidifying its IgA nephropathy treatment status, Etrasimod gained Hong Kong approval and is under review in Korea and Taiwan, with mainland China approval expected in H1 2026, EVER001 showed positive Phase 1b/2a data, and mRNA cancer vaccines EVM16 and EVM14, along with self-generating CAR-T projects, made significant progress - Nefecon® achieved full approval across all authorized regions, solidifying its cornerstone position as a first-line treatment for IgA nephropathy in Asia, and promoting treatment standardization[46] - Etrasimod received new drug marketing approval in Hong Kong SAR, with applications accepted in South Korea and Taiwan, and NMPA approval in mainland China expected in H1 2026[46] - EVER001 Phase 1b/2a trial for primary membranous nephropathy showed positive data, with anti-PLA2R antibody levels decreasing by nearly 100% and proteinuria levels by approximately 80%[47] - Personalized mRNA cancer vaccine EVM16 IIT completed dosing for 9 patients, with preliminary data expected in H2 this year[48] - Universal TAA mRNA vaccine EVM14 received US FDA IND approval and China NMPA acceptance, with US clinical studies planned for H2 2025[48] Commercialization In H1 2025, Nefecon® and Yijia® generated RMB 446 million in sales revenue, with Nefecon® experiencing rapid growth due to NRDL inclusion and expanded hospital coverage, Yijia® showing steady growth with increased hospital penetration, and Etrasimod initiating early use in Guangdong and local production - In H1 2025, Nefecon® and Yijia® generated RMB 446 million in sales revenue[50] - Nefecon®'s inclusion in the NRDL on January 1, 2025, led to rapid H1 sales growth and over 20,000 new patients[50] - Nefecon® was recommended as the preferred causal treatment in the "Chinese Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Pre-review Version)"[51] - Yijia®'s penetration increased in approximately 300 core hospitals, showing steady sales growth, with its China breakpoint approved by CDE and updated in the package insert[53] - Etrasimod is in early use in 9 medical institutions in Guangdong via the "Hong Kong and Macao Medicine and Medical Device Connect" policy, and the Jiaxing factory launched localized production with an estimated annual capacity of 5 million bottles[56] Commercialization Outlook In H2 2025, the company will accelerate commercialization and expand access to innovative therapies, with Nefecon® fully integrated into medical insurance and projected for RMB 1.2-1.4 billion in annual sales, Yijia® deepening hospital penetration, and Etrasimod advancing mainland China launch preparations - Nefecon® will achieve full medical insurance coverage in H2 and is expected to be included in the 2025 KDIGO IgA Nephropathy Guideline and China's first IgA nephropathy clinical guideline[57] - Nefecon®'s production capacity expansion approval paves the way for significant H2 2025 sales growth, with full-year sales projected at RMB 1.2 to 1.4 billion[58] - Yijia® will continue deep penetration in core hospitals, targeting high-potential institutions and optimizing its CSO cooperation model[58] - Combined full-year revenue for Nefecon® and Yijia® is projected to reach RMB 1.6 to 1.8 billion in 2025[58] - Etrasimod's mainland China launch preparations are advancing, setting the stage for rapid market entry post-NMPA approval in H1 2026[59] In-house R&D H1 2025 marked a critical execution period for the company's "dual-driver" strategy and mRNA platform, with personalized mRNA cancer vaccine EVM16 completing dosing for 9 patients showing good immunogenicity, universal TAA mRNA cancer vaccine EVM14 achieving dual US and China filings and releasing GMP clinical samples, and the mRNA self-generating CAR-T platform yielding multiple preclinical validation results - The company successfully hosted the "2025 Everest Medicines mRNA Innovation Technology Platform R&D Day," showcasing advancements in its proprietary AI-driven mRNA technology platform[60] - Personalized mRNA therapeutic cancer vaccine EVM16 IIT completed dosing for 9 patients, showing good immunogenicity by eliciting specific T-cell responses even at low starting doses[62] - Universal TAA mRNA cancer vaccine EVM14 achieved dual US and China filings and released the first batch of GMP clinical trial samples, validating the company's full-chain mRNA platform[63] - The mRNA self-generating CAR-T platform achieved multiple preclinical validation results, demonstrating efficacy in humanized mouse and non-human primate models, potentially revolutionizing traditional CAR-T therapies[64] - In H2 2025, personalized cancer vaccine EVM16 is expected to complete Phase Ia enrollment, EVM14 will start US dosing and may receive China IND approval, and the self-generating CAR-T platform is expected to identify clinical candidates[65] Business Development The 2025 business development strategy focuses on high clinical value, differentiated first-in-class or best-in-class assets in renal, autoimmune, and anti-infective diseases, seeking in-licensing opportunities for commercial or near-commercial assets, and global partnerships for early-stage assets like EVER001 and mRNA platform projects, while strategically increasing I-Mab equity to become its largest shareholder, deepening oncology immunotherapy - Business development focuses on high clinical value, differentiated first-in-class or best-in-class assets, prioritizing renal, autoimmune, and anti-infective diseases[66] - The company will seek in-licensed assets at commercial or near-commercial stages and actively pursue international collaboration for early-stage global assets[66][67] - One-year follow-up data for primary membranous nephropathy patients in the EVER001 (sibrotuzumab) Ib/IIa clinical trial is expected in September[67] - mRNA-based therapeutic cancer vaccine projects EVM16 and EVM14 will yield key preliminary human data in H2 this year and H1 next year, respectively, supporting potential global collaborations[67] - The company strategically increased its stake in I-Mab to approximately 16.1%, becoming its largest shareholder and advancing its global next-generation oncology immunotherapy pipeline[68] Financial Review For the six months ended