歌礼制药(01672) - 2025 - 中期业绩

Financial Summary Provides a concise overview of the company's financial performance for the six months ended June 30, 2025 Financial Summary for the Six Months Ended June 30, 2025 (Unaudited) | Metric | For the Six Months Ended June 30 (Unaudited) | Change (%) | | :--- | :--- | :--- | | | 2025 (RMB thousands) | 2024 (RMB thousands) | | | Total Revenue | 103,577 | 49,004 | 111.4% | | R&D Costs | (146,812) | (132,382) | 10.9% | | Administrative Expenses | (43,302) | (41,356) | 4.7% | | Loss Before Tax | (87,951) | (130,318) | -32.5% | | Loss for the Period | (87,951) | (130,318) | -32.5% | | Loss Per Share (Basic and Diluted) | (9.14) cents | (12.82) cents | -28.7% | Company Overview and Business Progress Details the company's strategic vision, overall business advancements, and pipeline development across key therapeutic areas Company Profile and Vision Ascletis aims to be a world-class innovative biopharmaceutical company addressing unmet global medical needs in metabolic diseases - Company vision: To be the most innovative world-class biopharmaceutical company, dedicated to addressing unmet global medical needs in metabolic diseases[5] Overall Business Overview The company made significant pipeline progress in metabolic and immune diseases, narrowing its loss for the period despite increased R&D investment - The company achieved significant progress in its R&D pipeline across multiple disease areas, including: - Obesity treatment: ASC30 oral tablet showed up to 6.5% weight loss in a US Ib study; ASC30 subcutaneous formulation had a half-life of 36 days, supporting monthly dosing; muscle-sparing candidate ASC47 completed enrollment for combination study with semaglutide - Immune diseases: Oral small molecule IL-17 inhibitor ASC50 initiated Phase I clinical study in the US - Expanded indications: FASN inhibitor denifanstat (ASC40) for acne achieved all primary endpoints in Phase III study[6] Financial Performance and Cash Position | Metric | 2025 H1 | 2024 H1 | Change | | :--- | :--- | :--- | :--- | | Loss for the Period | approx. 88.0 million RMB | approx. 130.3 million RMB | -32.5% | | R&D Costs | approx. 146.8 million RMB | approx. 132.4 million RMB | +10.9% | | Cash and Equivalents | approx. 1,827.9 million RMB | approx. 2,117.2 million RMB | - | - As of June 30, 2025, the Group's cash and equivalents reserves were approximately 1.828 billion RMB, projected to support R&D and operations until 2029[7] R&D Pipeline The company maintains three core pipelines: metabolic diseases, immune diseases, and expanded indications, with global or Greater China rights for various drug candidates - Metabolic Disease Pipeline: Core products for obesity, ASC30 (oral/subcutaneous) and ASC47 (subcutaneous), both with global rights and in clinical Phase IIa or Ib[8] - Immune Disease Pipeline: Core product, oral small molecule IL-17 inhibitor ASC50, for psoriasis and other immune diseases, with global rights, in clinical Phase I[9] - Expanded Indication Pipeline: Core product, oral small molecule FASN inhibitor ASC40, for acne, with Greater China rights, in Phase III[10] Management Discussion and Analysis Provides an in-depth review of the company's operational performance, financial results, and future outlook Business Review The company detailed clinical progress and key data for its core pipeline products, with notable advancements in metabolic disease drugs and strategic project adjustments Metabolic Diseases Significant progress in obesity drug pipeline, with ASC30 showing up to 6.5% weight loss and ASC47 demonstrating potential for healthy weight reduction - ASC30 Oral Tablet: In a US Phase Ib study, after 4 weeks of treatment, the placebo-adjusted average weight loss was up to 6.5%, with good tolerability. Its 13-week Phase IIa study has completed enrollment of 125 patients, with top-line data expected in Q4 2025[13][14] - ASC30 Subcutaneous Injection: In a US Phase Ib study, an ultra-long-acting formulation showed a half-life of 36 days in obese patients, supporting monthly or less frequent dosing. Phase IIa study has completed dosing of the first subjects[16][17] - ASC47 (Muscle-Sparing): A single subcutaneous injection in obese patients showed a half-life of 40 days, supporting monthly to bi-monthly dosing. The combination study with semaglutide has completed enrollment of all 28 subjects[18][19] Immune Diseases The company's self-developed novel oral small molecule IL-17 inhibitor ASC50 has initiated a Phase I clinical trial in the US for psoriasis - The novel oral small molecule IL-17 inhibitor ASC50 has initiated a Phase I clinical trial in the US for psoriasis, with potential to be a best-in-class daily oral drug[21] - ASC50 is the company's first immunology candidate developed through its structure-based AI-assisted drug discovery (AISBDD) platform[22] Expanded Indications and Others FASN inhibitor denifanstat (ASC40) successfully completed Phase III trials for acne, while the rGBM project was terminated, and out-licensing opportunities are being sought for other assets - ASC40 for Acne: Phase III clinical trial achieved success, with all endpoints showing highly statistically significant improvements and good safety. Efficacy was superior to FDA-approved drugs like sarecycline and doxycycline. The company plans to seek commercial partnerships in 2025[24][25][26] - Project Termination and Out-licensing: Based on study results, the company decided to terminate the ASC40 project for recurrent glioblastoma (rGBM). For ASC40 in MASH and ASC61 for solid tumors, the company will seek opportunities to maximize project value, including out-licensing[27][28][30] Preclinical Discovery The company continues to leverage its AI-assisted drug discovery (AISBDD) and ultra-long-acting drug development (ULAP) platforms to strengthen early-stage R&D - The company continues to strengthen early-stage discovery by leveraging its two core platforms (AISBDD and ULAP) to develop more globally competitive small molecule and peptide pipeline products[31] Future and Outlook The company's H2 2025 strategy focuses on advancing core clinical programs, obtaining key data, strengthening early R&D, and pursuing out-licensing opportunities - Key Outlook for H2 2025: - Obtain Key Clinical Data: Expected top-line data from US clinical studies for ASC30 oral tablet (obesity), ASC47 combination therapy (obesity), and ASC50 (psoriasis) - Advance Clinical Enrollment: Complete enrollment for all subjects in the US Phase IIa study of ASC30 monthly subcutaneous injection (obesity) - Strengthen Early R&D: Accelerate peptide pipeline clinical trials using the ULAP platform - Seek Out-licensing: Actively pursue collaboration opportunities with global pharmaceutical companies[35] Financial Position Analysis The company's total revenue increased significantly, driven by fair value gains and government grants, while R&D expenses rose, and financial ratios improved, indicating a robust financial position Revenue and Other Income Total revenue increased by 111.4% to 103.6 million RMB, primarily due to higher fair value gains from financial assets and increased government grants - Total revenue (revenue, other income and gains) increased by 111.4% from 49.0 million RMB to 103.6 million RMB, primarily due to an increase in other income and gains[37] Details of Other Income and Gains (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Bank interest income | 30,037 | 48,076 | | Government grants | 34,175 | 12,226 | | Net fair value gain/(loss) on financial assets | 39,151 | (10,735) | | Gain on dilution of interest in an associate | – | 21,147 | | Loss on remeasurement of interest in an associate | – | (24,546) | | Total | 102,496 | 49,004 | Costs and Expenses R&D expenses increased by 10.9% to 146.8 million RMB, mainly due to increased investment in the metabolic disease pipeline, while administrative expenses slightly rose - R&D expenses increased by 10.9% to 146.8 million RMB, primarily due to increased investment in the metabolic disease product pipeline[43][44] R&D Costs by Product Pipeline (RMB thousands) | Product Pipeline | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Metabolic Diseases | 42,640 | 27,037 | | Expanded Indications - Acne | 43,970 | 47,182 | | Expanded Indications - Oncology | 15,259 | 15,807 | | Preclinical | 38,023 | 14,486 | | Total | 146,812 | 132,382 | - Administrative expenses increased by 4.7% to 43.3 million RMB, primarily due to higher staff costs and benefits[41][42] Key Balance Sheet Items Inventories, trade receivables, and financial assets increased, with non-current financial assets significantly rising due to fair value gains on listed equity securities, while other payables decreased - Non-current financial assets at fair value through profit or loss increased from 53.5 million RMB to 79.3 million RMB, primarily due to an increase in the fair value of investments in NASDAQ-listed equity securities[59] - Total other payables and accrued expenses decreased from 145.2 million RMB to 119.9 million RMB, with provisions reduced by 11.2 million RMB due to arbitration settlement[64][66] Liquidity and Capital Resources The company held 1.828 billion RMB in cash and equivalents, with net cash outflow from operating activities and net inflow from investing activities, primarily from maturing time deposits Condensed Consolidated Cash Flow Statement Summary (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Net cash flow (used in) operating activities | (172,990) | (203,415) | | Net cash flow from investing activities | 904,605 | 261,633 | | Net cash flow (used in) financing activities | (14,485) | (45,455) | | Net increase in cash and cash equivalents | 717,130 | 12,763 | - Net cash inflow from investing activities was primarily due to a decrease of approximately 864 million RMB in time deposits with original maturity over three months[71] - Net cash outflow from financing activities was primarily due to share repurchases totaling approximately 12.8 million RMB[72] Key Financial Ratios The company's liquidity improved, with current and quick ratios increasing, and the debt-to-asset ratio decreasing, indicating a more robust financial structure Key Financial Ratios | Ratio | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 14.6 | 12.9 | | Quick Ratio | 14.5 | 12.8 | | Debt-to-Asset Ratio | 6.5% | 7.5% | - The increase in current and quick ratios and the decrease in the debt-to-asset ratio were primarily due to a reduction in current liabilities[82] Other Information The company disclosed litigation updates with Viking Therapeutics, including provisions for ITC fines, and detailed its employee structure and compensation policy Litigation and Contingent Liabilities The company disclosed litigation with Viking Therapeutics, making provisions for an ITC fine of approximately $567,000 while actively defending the ongoing USDC lawsuit - Regarding the litigation with Viking Therapeutics, the ITC's recommended judgment imposed a fine of approximately $567,000, for which the company has made provisions[76] - The lawsuit filed with the USDC is ongoing, and the company will actively defend it, with no provisions made as of the end of the reporting period[77] Employees and Remuneration Policy As of June 30, 2025, the Group had 208 employees, with 65.9% in R&D, reflecting its research-centric strategy, and total employee costs increased Number of Employees by Function (as of June 30, 2025) | Function | Number of Employees | % of Total | | :--- | :--- | :--- | | Management | 4 | 1.9% | | R&D | 137 | 65.9% | | Manufacturing | 29 | 13.9% | | Operations | 38 | 18.3% | | Total | 208 | 100.0% | - For the six months ended June 30, 2025, total employee costs were approximately 82.1 million RMB, compared to 76.8 million RMB in the prior period[84] Consolidated Financial Statements Presents the company's consolidated financial performance and position, including the income statement and balance sheet Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, the company reported revenue of 1.08 million RMB and a loss of 87.95 million RMB, a 32.5% reduction from the prior year Summary of Consolidated Statement of Profit or Loss (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Revenue | 1,081 | – | | Other income and gains | 102,496 | 49,004 | | R&D costs | (146,812) | (132,382) | | Administrative expenses | (43,302) | (41,356) | | Loss before tax | (87,951) | (130,318) | | Loss for the period | (87,951) | (130,318) | Consolidated Statement of Financial Position As of June 30, 2025, the company reported total assets of 1.997 billion RMB, total liabilities of 129.0 million RMB, and net assets of 1.868 billion RMB, indicating strong liquidity Summary of Consolidated Statement of Financial Position (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total non-current assets | 173,899 | 153,790 | | Total current assets | 1,822,936 | 1,970,782 | | Total assets | 1,996,835 | 2,124,572 | | Total current liabilities | 125,125 | 153,053 | | Total non-current liabilities | 3,873 | 5,357 | | Total liabilities | 129,000 | 158,410 | | Net assets | 1,867,837 | 1,966,162 | Notes to Interim Financial Report Provides detailed explanations and disclosures supporting the interim financial statements, covering accounting policies, revenue, capital, and dividends Company Information and Basis of Preparation This unaudited interim financial report, reviewed by KPMG, details the company's primary engagement in drug R&D and its listing on the HKEX - This interim financial report is unaudited but has been reviewed by KPMG in accordance with Hong Kong Standard on Review Engagements 2410[96] - The company is an investment holding company, with subsidiaries primarily engaged in drug R&D. Its shares were listed on the Main Board of the Stock Exchange of Hong Kong on August 1, 2018[93][94] Revenue and Segment Reporting Revenue for the period was 1.08 million RMB, primarily from R&D services, with the company managed as a single operating segment and revenue mainly from Hong Kong - Revenue for the reporting period was 1,081 thousand RMB, primarily from providing R&D services (1,054 thousand RMB)[100] - The company operates as a single operating segment, thus no segment information is presented[102] Capital, Reserves and Dividends The board did not recommend an interim dividend, while the company repurchased 3.44 million shares and issued new shares from option exercises, also canceling repurchased shares - The Board does not recommend the payment of any dividend for the six months ended June 30, 2025[113] - During the interim period, the company repurchased shares on the Stock Exchange of Hong Kong for a total consideration of 13.81 million HKD (equivalent to 12.76 million RMB)[115] - During the reporting period, the company cancelled 44,896,790 shares[117] Other Disclosure Information Covers corporate governance practices, details of securities transactions including share repurchases, and the review process for interim results Corporate Governance The company adheres to the Corporate Governance Code, with the only deviation being Dr. Wu holding both Chairman and CEO roles for efficient leadership - The company has complied with the Corporate Governance Code during the reporting period, except that the roles of Chairman and Chief Executive Officer are not separate, both held by Dr. Wu. The Board believes this arrangement provides more efficient leadership[120] Securities Transactions and Share Repurchases The company repurchased 3.44 million shares for 13.559 million HKD to enhance shareholder value and holds treasury shares for its share award scheme Details of Share Repurchases During the Reporting Period | Month of Transaction | Number of Shares Repurchased | Highest Price Per Share (HKD) | Lowest Price Per Share (HKD) | Total Consideration (HKD) | | :--- | :--- | :--- | :--- | :--- | | January 2025 | 2,640,000 | 4.13 | 2.94 | 9,301,470.00 | | April 2025 | 800,000 | 6.74 | 4.57 | 4,257,980.00 | - As of June 30, 2025, the company held 5,784,210 treasury shares for its 2025 share award scheme[123] Review of Interim Results KPMG, the independent auditor, reviewed the interim financial information, and the Audit Committee confirmed its compliance with accounting standards and regulations - The company's independent auditor, KPMG, has reviewed the interim financial information[125] - The Audit Committee, comprising three independent non-executive directors, has reviewed the interim results and found them to be in compliance with applicable accounting standards and regulations[125]