华昊中天医药(02563) - 2024 - 年度业绩

Performance Overview The company significantly narrowed its annual loss in FY2024, driven by robust revenue growth, improved gross profit, and effective cost control Financial Highlights In FY2024, the company achieved revenue growth and significant gross profit increase, leading to a 24.2% reduction in annual loss, alongside high R&D investment and increased cash reserves Financial Highlights Summary | Metric | 2024 (RMB thousands) | 2023 (RMB thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 71,866 | 66,635 | 7.9% | | Gross Profit | 61,086 | 46,825 | 30.5% | | Loss Before Tax | -143,776 | -189,644 | -24.2% | | Loss for the Year | -143,776 | -189,644 | -24.2% | | Loss Per Share | -0.41 | -0.54 | -24.1% | | R&D Expenses | -116,292 | -126,537 | -8.1% | | Cash and Equivalents, Restricted Balances, and Time Deposits | 466,636 | 340,405 | 37.1% | Management Discussion and Analysis The company made significant progress in pipeline development, strategic partnerships, intellectual property, and production optimization, advancing its core products and global strategy Business Review The company, a synthetic biology-driven biopharmaceutical firm, achieved significant progress in pipeline development, strategic collaborations, intellectual property, and production optimization, advancing its core products and global market presence - The company is a synthetic biology-driven biopharmaceutical company focused on developing innovative oncology drugs, possessing three core technology platforms[6] - As of the end of the reporting period, the company has 1 commercialized product (Utidelone Injection) and 19 R&D pipeline candidates[6] R&D Pipeline Advancement The company's R&D pipeline, centered on Utidelone injection and oral capsules, advanced significantly with positive clinical trial results for new indications and combination therapies, accelerating global multi-center studies - Utidelone Injection is the only chemotherapy drug developed using synthetic biology technology and approved for market, and the only microtubule inhibitor oncology drug with a novel molecular structure approved globally since 2010[6] - The company is actively expanding Utidelone's clinical development both domestically and internationally, including new indication expansion (e.g., non-small cell lung cancer, pancreatic cancer, brain metastases) and oral formulation development[7] Core Product: Utidelone Injection Utidelone Injection demonstrated positive clinical progress across multiple indications, including HER2-negative breast cancer, NSCLC, gastric/esophageal cancer, and notably, encouraging efficacy in brain metastasis treatment - Phase III clinical trial for HER2-negative breast cancer neoadjuvant therapy has completed 2/3 patient enrollment, with full enrollment expected by H2 2025[10] - Phase II clinical trial for advanced NSCLC showed an ORR of 19.0%, DCR of 81.0%, and median PFS of 4.4 months[11] - In the Phase II clinical trial for HER2-negative breast cancer brain metastases, CNS-ORR reached 42.6%, median PFS was 7.7 months, and median OS reached 15.1 months[16] - The US pivotal Phase II clinical trial for breast cancer brain metastases has received IND approval and is about to enroll its first patient, marking a significant step in the company's internationalization strategy[22] Core Product: Utidelone Capsules Utidelone Capsules, an oral formulation, completed Phase I studies in China and the US with good bioavailability and safety, and is advancing multiple Phase II/III trials for various cancers, targeting a pre-NDA submission for advanced breast cancer in Q4 2025 - China Phase I clinical study showed Utidelone Capsules' bioavailability (F%) at 35.1%, demonstrating promising prospects as a monotherapy[27] - In the China pivotal clinical study combining with Capecitabine for advanced breast cancer, ORR exceeded 56.8%, CBR was 88.6%, with a pre-NDA submission planned for Q4 2025[28][29] - US Phase I clinical study determined the maximum tolerated dose (MTD), showing an ORR of 18.2% and CBR of 81.8% in heavily pre-treated advanced solid tumor patients[31] - The company has initiated three large international multi-center Phase II/III clinical studies for advanced gastric cancer, advanced ovarian cancer, and triple-negative breast cancer adjuvant intensification therapy, respectively[34][36] Utidelone Antibody-Drug Conjugates (ADCs) The company is actively developing Utidelone as a payload for Antibody-Drug Conjugates (ADCs), aiming to leverage its clinical advantages to enhance efficacy and safety across various indications - The company is actively developing ADC projects using Utidelone as the payload to enrich its product portfolio, with plans to advance them to clinical stage as soon as possible[37][42] Market Promotion Strategic Cooperation To accelerate commercialization, the company partnered with Baiyang Zhihe for exclusive market promotion rights of Utidelone Injection in mainland China, effective January 1, 2025 - On November 14, 2024, the company signed an exclusive market promotion service agreement with Baiyang Zhihe, which has paid a non-refundable upfront payment of RMB 50 million[38] - The cooperation agreement also includes milestone payments based on R&D and sales progress, with the company paying promotion service fees to Baiyang Zhihe based on a tiered percentage of annual terminal sales[38] Intellectual Property The company secured multiple key PCT patents for Utidelone crystal forms, oral formulations, and high-yield engineered bacteria, with the core high-yield strain patent protected until 2041, significantly enhancing anti-imitation barriers - The company obtained multiple key PCT patent grants during the reporting period, covering crystal forms, oral formulations, and genetically engineered bacteria for production[39] - The high-yield strain patent for Utidelone production is a core patent, protected until 2041, significantly raising the barrier to generic imitation due to the critical role of microbial fermentation in production[39][40] Production and Quality Optimization The company continuously optimized production and quality control by localizing consumables, expanding production batches, introducing a new Utidelone Injection specification, and enhancing its quality management system - Exploration of domestic sourcing for culture media and consumables reduced production costs and enhanced supply chain stability while maintaining quality[41] - To meet growing market demand, the company expanded production batches for Utidelone Injection and completed regulatory filing[41] - A new 3ml:30mg specification for Utidelone Injection was added to better meet clinical needs, approved in December 2024[41] Development Strategy and Business Outlook The company plans to strengthen R&D, globalize its pipeline, advance Utidelone clinical trials and ADC development, optimize production, deepen partnerships, and cultivate talent to support future growth - Continuously advance clinical trials for Utidelone Injection and Capsules, covering multiple indications such as breast cancer neoadjuvant, NSCLC, brain metastases, gastric cancer, and ovarian cancer, while accelerating overseas market applications[42] - Fully develop ADC projects with Utidelone as the payload and advance them to clinical stage as soon as possible[42] - Plan to upgrade production facilities to cGMP standards to ensure global product supply[43] - Deepen cooperation with partner Baiyang Pharmaceutical to formulate comprehensive academic promotion and commercialization strategies, rapidly increasing product market penetration[44] Financial Review The company's financial performance in FY2024 was marked by increased revenue and gross profit, reduced operating losses, and a stable financial position with healthy liquidity Revenue and Gross Profit In 2024, revenue grew by 7.9% to RMB 71.9 million, while gross profit significantly increased by 30.5% to RMB 61.1 million, with gross margin improving to 85.0%, driven by enhanced market penetration and optimized production costs Revenue and Gross Profit Summary | Metric | 2024 (RMB millions) | 2023 (RMB millions) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 71.9 | 66.6 | +7.9% | | Cost of Sales | 10.8 | 19.8 | -45.6% | | Gross Profit | 61.1 | 46.8 | +30.5% | | Gross Margin | 85.0% | 70.3% | +14.7pp | Operating Expenses and Annual Loss The company's annual loss narrowed from RMB 189.6 million to RMB 143.8 million due to effective control over sales and distribution expenses and reduced R&D spending, despite an increase in administrative costs Operating Expenses Summary | Expense Item | 2024 (RMB millions) | 2023 (RMB millions) | YoY Change | | :--- | :--- | :--- | :--- | | Sales and Distribution Expenses | 61.9 | 95.4 | -35.1% | | Administrative Expenses | 52.3 | 43.9 | +19.2% | | R&D Expenses | 116.3 | 126.5 | -8.1% | - Due to increased gross profit and expense control, the annual loss narrowed from RMB 189.6 million in 2023 to RMB 143.8 million in 2024[53] Financial Position and Liquidity As of 2024 year-end, the company maintained a stable financial position with increased net current assets and cash reserves, primarily from its global offering, despite shifts in liquidity ratios Key Financial Ratios | Key Financial Ratios | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Current Ratio (times) | 8.8 | 14.5 | | Quick Ratio (times) | 8.4 | 13.9 | | Debt-to-Asset Ratio (%) | 13.4% | 6.4% | - As of December 31, 2024, cash and cash equivalents, bank time deposits, restricted bank balances, and financial assets totaled RMB 607.6 million, a 5.5% year-on-year increase[59] Employees and Remuneration Policy As of 2024 year-end, the Group had 147 employees, with total annual remuneration costs of RMB 80.5 million, supported by a comprehensive compensation and incentive framework Employee and Remuneration Summary | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Total Employees | 147 | - | | Total Remuneration Costs (RMB millions) | 80.5 | 120.3 | Corporate Governance and Other Information The company's corporate governance section addresses the use of global offering proceeds, an independent auditor's qualified opinion, and the dividend policy Use of Proceeds from Global Offering The company's HKD 196 million net proceeds from its October 2024 global offering remained unutilized as of year-end, despite temporary, inadvertent deviations that have since been fully rectified with enhanced internal controls - Net proceeds from the global offering were approximately HKD 195.89 million, unutilized as of December 31, 2024[70][71] - During the reporting period, the company temporarily deviated from the intended use of IPO proceeds for fund subscriptions and internal temporary loans, but emphasized these were "inadvertent errors" and all related amounts have been fully recovered[66][74][76] - To prevent similar incidents, the company has implemented remedial measures, including strengthening listing rule training, communicating with compliance advisors, and formulating a "Proceeds Management Policy"[77][78] Summary of Independent Auditor's Report The independent auditor issued a "qualified opinion" on the 2024 consolidated financial statements due to insufficient audit evidence regarding the fair value of an unlisted fund investment valued at approximately RMB 35.94 million - The independent auditor issued a "qualified opinion" on the 2024 consolidated financial statements[81] - The fundamental reason for the qualified opinion is the auditor's inability to obtain sufficient and appropriate audit evidence regarding the fair value of the Group's USD 5 million (approximately RMB 35.942 million) investment in an unlisted fund[82][83] - The auditor could not determine if the fair value of this fund investment as of December 31, 2024, was properly determined, or if any adjustments or additional disclosures were required for the related amounts[83] Dividend Policy The Board has resolved not to recommend the payment of a final dividend for the year ended December 31, 2024 - No final dividend is recommended for FY2024[87] Consolidated Financial Statements and Notes This section presents the consolidated financial statements, including the income statement, balance sheet, and detailed notes on accounting policies and key financial items Consolidated Statement of Profit or Loss and Other Comprehensive Income In FY2024, the company reported RMB 71.87 million in revenue and RMB 61.09 million in gross profit, with a narrowed loss before tax and loss for the year of RMB 143.8 million, resulting in a basic and diluted loss per share of RMB 0.41 Consolidated Statement of Profit or Loss and Other Comprehensive Income | Item (RMB thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Revenue | 71,866 | 66,635 | | Gross Profit | 61,086 | 46,825 | | Sales and Distribution Expenses | (61,926) | (95,397) | | Administrative Expenses | (52,339) | (43,900) | | R&D Expenses | (116,292) | (126,537) | | Loss Before Tax | (143,776) | (189,644) | | Loss for the Year | (143,776) | (189,644) | | Loss Per Share (RMB) | (0.41) | (0.54) | Consolidated Statement of Financial Position As of 2024 year-end, the company reported total assets of RMB 913 million, total liabilities of RMB 122 million, and net assets of RMB 791 million, with significant growth in non-current assets and overall equity Consolidated Statement of Financial Position | Item (RMB thousands) | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Non-current Assets | 213,985 | 138,814 | | Current Assets | 699,258 | 633,530 | | Total Assets | 913,243 | 772,344 | | Liabilities and Equity | | | | Current Liabilities | 79,161 | 43,743 | | Non-current Liabilities | 43,336 | 5,440 | | Total Liabilities | 122,497 | 49,183 | | Net Assets/Total Equity | 790,746 | 723,161 | Summary of Notes to Financial Statements The notes detail key accounting policies, revenue sources, and significant financial items, including an unlisted fund investment subject to a qualified audit opinion and recovered prepayments for unsuccessful fund subscriptions - Note 10(iii) details the unlisted fund investment leading to the auditor's qualified opinion: a USD 5 million investment in Cayman Islands-registered Fund C in November 2024, with directors believing its year-end fair value equals historical cost[122] - Note 12(i) discloses that the company prepaid a total of RMB 55.623 million in November 2024 for subscriptions to two other funds (Fund A and Fund B), but the subscriptions were unsuccessful, and the amounts were requested for withdrawal and fully refunded in February 2025[126] - Note 4(b) states that no geographical segment information is presented as the Group's revenue and operating loss primarily originate from China, and all non-current assets are located in China[109]