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再鼎医药:发展迎来拐点,研发进入全球化新阶段
09688ZAI LAB(09688) 广发证券·2024-12-29 06:44

Investment Rating - The report gives a "Buy" rating for the company with a target price of HKD 33.70 per share [17] Core Views - The company is at a critical inflection point, aiming to achieve profitability by the end of 2025 [1] - Commercial sales are rapidly expanding, with product sales reaching USD 289 million in the first three quarters of 2024, a 44% YoY increase [2] - The company's revenue CAGR from 2023 to 2028 is expected to be around 50% [2] - The company has three global rights pipelines in clinical stages, with ZL-1310 showing potential as a best-in-class DLL3 ADC [3] Revenue and Profit Forecast - Revenue is expected to grow from USD 387 million in 2024 to USD 856 million in 2026, with a CAGR of 45% [3][17] - EBITDA is projected to improve from a loss of USD 297 million in 2024 to a near break-even of USD -8 million in 2026 [3] - Net profit is expected to turn positive by 2026, reaching USD 41 million [3] Product Pipeline and Commercialization - The company has a differentiated global pipeline with products like ZL-1310 (DLL3 ADC), ZL-1102 (IL-17A), and ZL-1218 (CCR8) in clinical stages [3] - Key products such as Niraparib, Tumor Treating Fields, and Repotrectinib have been approved and are contributing to revenue growth [42][73] - The company is focusing on global rights pipelines, with ZL-1310 showing promising Phase Ia data [3] Key Products and Market Potential - Efgartigimod (FcRn antagonist): Rapid sales growth post-approval, with Q1-Q3 2024 sales reaching USD 63.6 million in China [78] - KarXT (M1/M4 receptor agonist): Expected to revolutionize schizophrenia treatment, with potential for approval in China by 2026 [60][122] - Bemarituzumab (FGFR2b monoclonal antibody): Shows promise in gastric cancer, with Phase III trials expected to read out in 2025 [97][103] - Tumor Treating Fields: Positive results in pancreatic cancer Phase III trials, with potential for new indications [106][107] Financial Efficiency - R&D expenses in Q1-Q3 2024 were USD 182 million, a 1% YoY decrease, with an R&D expense ratio of 63% [46] - SG&A expenses were USD 216 million, a 9% YoY increase, with an expense ratio of 75% [46] - Net loss in Q1-Q3 2024 was USD 175 million, a reduction of USD 64 million compared to the previous year [46] Strategic Partnerships and Licensing - The company has secured strategic partnerships with global biopharma companies, including Argenx for Efgartigimod and Karuna Therapeutics for KarXT [40][89] - Licensing agreements have been instrumental in building a differentiated product pipeline, with products like Niraparib and Tumor Treating Fields contributing significantly to revenue [40][71] Market and Industry Context - The company operates in the biopharmaceutical sector, focusing on oncology, autoimmune diseases, CNS disorders, and infectious diseases [38][42] - The global rights pipeline and strategic partnerships position the company for long-term growth in both domestic and international markets [3][71]