Investment Rating - The report maintains a "BUY" rating for Kelun-Biotech [2][4][17]. Core Insights - Kelun-Biotech recorded RMB1.54 billion in revenue for FY23, primarily from licensing and collaboration agreements with MSD, with a significant upfront payment of RMB1.21 billion received in March 2023 [2][11]. - The company expects to receive over US$100 million in payments from MSD in FY24, indicating strong future revenue potential [2]. - The net loss for FY23 decreased to RMB574 million from RMB616 million in FY22, showing improvement in financial performance [2][11]. - SKB264 is anticipated to unlock commercial value upon approval in China in the second half of 2024, with ongoing clinical trials expected to validate its global potential [2][3]. - The company is preparing for domestic commercialization by building a commercial team, expected to grow to approximately 500 employees by the end of 2024 [2][4]. Financial Summary - Revenue for FY23 was RMB1.54 billion, a 91.6% increase year-over-year, while FY24 revenue is projected to decline by 40.4% to RMB918 million [3][11]. - R&D expenses increased by 21.9% year-over-year to RMB1.03 billion in FY23, reflecting the company's commitment to advancing its clinical trials [2][11]. - The company had a cash balance of RMB2.53 billion at the end of 2023, providing a solid financial foundation for ongoing operations [2][11]. Clinical Development - SKB264's NDA for 3L+ TNBC has been under review since December 2023, with approval expected in 2H24 [2]. - The company has initiated a Phase 3 trial for SKB264 in 1L TNBC treatment and plans to start pivotal trials in various indications, including NSCLC and HR+/HER2- BC [2][6]. - MSD is actively registering multiple global Phase 3 trials for SKB264, enhancing its development prospects [2][6]. Valuation - The report revises the DCF-based target price from HK$189.25 to HK$200.77, reflecting a potential upside of 25% from the current price of HK$160.60 [4][9].
Intense data release to further validate the global potential of SKB264