瑞科生物(02179) - 2024 - 中期业绩

Performance Overview Business Summary The company advanced core vaccine development, with REC603 (HPV) in late-stage Phase III and REC610 (Shingles) nearing Phase III, while ceasing COVID-19 vaccine development and repurposing facilities - The core product, recombinant nine-valent HPV vaccine (REC603), is undergoing 36-month follow-up visits in Phase III clinical trials, with BLA submission anticipated in 2025 upon meeting conditions, positioning it among the leading domestic candidates[1] - The novel adjuvant recombinant shingles vaccine (REC610) has completed final vaccinations in China Phase I clinical trials, demonstrating good safety, with Phase III clinical studies expected to commence in 2024[2] - Due to low market demand, the company will not proceed with a new round of clinical development for the existing strain COVID-19 vaccine project (ReCOV) and will deregister related subsidiaries, but the established production base will be repurposed to advance the industrialization of shingles and RSV vaccines[4] Financial Summary For the six months ended June 30, 2024, the company remained in the R&D investment phase with no primary operating revenue, reporting a narrowed loss of RMB 249.6 million compared to RMB 276.9 million last year, with improved basic loss per share of RMB 0.52, while total assets decreased and total liabilities increased, leading to a decline in total equity Key Financial Data for H1 2024 (Consolidated Statements) | Indicator | H1 2024 (RMB Thousand) | H1 2023 (RMB Thousand) | | :--- | :--- | :--- | | Income Statement: | | | | Other Income and Gains | 35,701 | 59,929 | | Loss for the Period | (249,636) | (276,941) | | Loss Attributable to Owners of the Parent | (249,135) | (272,549) | | Loss Per Share (RMB) | (0.52) | (0.57) | | Balance Sheet (Period-End): | June 30, 2024 | Dec 31, 2023 | | Total Assets | 2,058,715 | 2,186,277 | | Total Liabilities | 1,222,954 | 1,115,333 | | Total Equity | 835,761 | 1,070,944 | Management Discussion & Analysis Business Review and R&D Pipeline The company, an innovation-driven vaccine firm, strategically develops over 10 candidates across major disease areas, leveraging three core technology platforms, with REC603 (HPV) in Phase III and REC610 (Shingles) nearing Phase III, supported by GMP-compliant production and international partnerships - The company possesses over 10 vaccine candidates, strategically focusing on three key products: recombinant nine-valent HPV vaccine (REC603), novel adjuvant recombinant shingles vaccine (REC610), and bivalent recombinant respiratory syncytial virus vaccine[29][30] - The company has established three core technology platforms—novel adjuvants, protein engineering, and immune evaluation—forming a 'golden triangle' synergy to support continuous vaccine innovation and development[29][46][50] - The company has established a WHO PQ-compliant HPV vaccine production base in Taizhou with a designed annual capacity of 20 million doses, and an EU GMP-compliant innovative vaccine production base, laying the foundation for future commercial manufacturing[29][52] - The company is actively advancing its internationalization strategy, having signed commercialization framework agreements for the nine-valent HPV vaccine REC603 with enterprises in multiple countries and regions, including Saudi Arabia, Argentina, and Russia[52] HPV Vaccine Pipeline HPV vaccines are the company's core pipeline, with flagship REC603 (nine-valent) in Phase III, expected for BLA submission in 2025, demonstrating positive immunogenicity and safety, alongside development of bivalent and next-generation HPV vaccines - The core product REC603 (nine-valent HPV vaccine) Phase III clinical trial is undergoing its 36-month follow-up visit, with BLA submission planned for 2025, featuring a randomized, double-blind, placebo-controlled design strictly adhering to guidelines, and boasting China's largest sample size of 16,050 cases[34][38] - REC603 utilizes the Hansenula polymorpha expression system, enabling high-yield and stable production of virus-like particles suitable for commercial manufacturing, and has demonstrated good safety, with an adverse event incidence rate of 53.75% in Phase I clinical trials, lower than historical data for marketed products[35][36] - The company is simultaneously developing bivalent HPV vaccines (REC601/REC602, Phase I completed) and next-generation HPV vaccines (REC604a/b) utilizing novel adjuvants, with REC604a having received clinical trial approval in China[38][39][40] Shingles Vaccine Pipeline The novel adjuvant recombinant shingles vaccine REC610, having completed China Phase I with good safety, is expected to enter Phase III in 2024, and previously showed comparable or numerically superior safety and immunogenicity against Shingrix® in a head-to-head FIH study - REC610's China Phase I clinical trial has completed final vaccinations for 180 subjects, demonstrating good safety with no SAEs reported, and based on these results, Phase III clinical studies are expected to commence in 2024[41] - In a head-to-head FIH study against Shingrix® in the Philippines, REC610 induced gE-specific humoral and cellular immune responses comparable to, and numerically higher than, Shingrix®[41][42] - REC610 incorporates the company's independently developed novel adjuvant BFA01, aiming to provide a domestic alternative for shingles prevention for approximately 700 million people aged 40 and above in China[42] Other Vaccine Pipelines The company has pipelines in RSV, influenza, and cytomegalovirus, with bivalent RSV vaccine REC625 planned to complete preclinical studies in 2024, and the suspended COVID-19 vaccine ReCOV project's production system will support other pipeline development - Preclinical studies for the bivalent recombinant RSV vaccine (REC625) have shown good immunogenicity, with preclinical research planned for completion in 2024[43] - Due to low market demand, the recombinant COVID-19 vaccine (ReCOV) project has ceased a new round of clinical development, but the GMP-compliant production facilities established for this project will be utilized to support the subsequent development of products like REC610 and REC625[44] - The company has also strategically positioned several early-stage vaccine projects, including those for influenza, cytomegalovirus, hepatitis B, and herpes simplex virus[45] Financial Review In H1 2024, the company's loss narrowed to RMB 250 million due to controlled R&D and administrative expenses, but cash and bank balances decreased to RMB 598 million, current ratio dropped from 2.5 to 1.2, and gearing ratio rose from 51.0% to 59.4%, indicating funding pressure Key Expense Item Changes | Expense Item | H1 2024 (RMB Million) | H1 2023 (RMB Million) | YoY Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 205.2 | 247.8 | -17.2% | | Administrative Expenses | 54.7 | 78.1 | -30.0% | | Selling and Distribution Expenses | 1.5 | 5.4 | -72.2% | - The decrease in R&D expenses is primarily due to core product REC603 entering the late-stage Phase III clinical follow-up phase, resulting in reduced clinical trial expenditures[58] - Cash and bank balances decreased from RMB 912 million at the end of 2023 to RMB 598 million, primarily utilized for R&D, industrialization construction, and administrative expenses[66][70] - The gearing ratio increased from 51.0% to 59.4%, and the current ratio decreased from 2.5 to 1.2, primarily due to increased bank borrowings and reduced cash[73] Business Outlook and Strategy The company will prioritize the expedited market launch of nine-valent HPV and recombinant shingles vaccines, focusing on accelerating clinical and commercialization processes, strengthening R&D, optimizing structure, and building market competitiveness through international BD and industrial cooperation - The core strategy is to concentrate resources and prioritize the market launch of the nine-valent HPV vaccine and recombinant shingles vaccine[55] - Strengthen international business development (BD) capabilities to achieve greater breakthroughs in international markets and outbound commercial licensing[55] - Prepare for product commercialization by developing intelligent manufacturing, strengthening quality systems, and building a marketing network[55] Other Information Corporate Governance and Compliance The company maintains high corporate governance standards, largely complying with the code, though the Chairman and CEO roles are combined (Dr. Liu Yong) for business efficiency, and the Audit Committee, along with Ernst & Young, has reviewed the interim financial results - The roles of Chairman and General Manager (CEO) are concurrently held by Dr. Liu Yong, constituting a deviation from Corporate Governance Code Provision C.2.1, which the Board believes benefits the company's business prospects and operational efficiency[83] - The Board confirms its responsibility for risk management and internal control systems, with no significant internal control deficiencies or reports of improper conduct identified during the reporting period[84] - The Audit Committee has reviewed the current period's results, and the interim financial report has been reviewed by Ernst & Young in accordance with relevant standards[85] - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2024[85]