Summary of CARsgen Therapeutics Earnings Review Company Overview - **Company**: CARsgen Therapeutics (2171.HK) - **Industry**: Biotechnology, specifically focusing on CAR-T therapy Key Financial Highlights - **Sales Growth**: 1H sales of zevor-cel reached Rmb 48 million, representing a 55% increase half-on-half, exceeding the guidance of Rmb 39 million [1] - **Order Confirmation**: 111 confirmed orders for zevor-cel were received in 1H25 from Huadong Medicine, indicating strong market demand [1] - **Adjusted Net Loss**: The adjusted net loss narrowed to Rmb 134 million from Rmb 289 million in 1H24, attributed to increased revenue and improved gross profit margin (GPM) of 55% compared to 36% in 2H24 [2] - **Operating Expenses**: Administrative expenses decreased by 55% year-on-year to Rmb 39 million, and R&D expenses fell by 47% to Rmb 130 million due to the completion of trials for CT041 [2] Market Dynamics - **Market Penetration**: The growth in market orders for zevor-cel appears to be slowing after initial adoption, with future growth dependent on the expansion of commercial insurance coverage [1] - **Insurance Coverage**: Management highlighted the importance of the recently introduced commercial insurance novel drug list by NHSA in expanding patient coverage for zevor-cel [1] Upcoming Catalysts - **CT041 (CLDN18.2 CAR-T)**: Preliminary data for pancreatic cancer treatment is expected at ESMO2025, with China approval anticipated in 1H26 [3] - **CT0596 (allogeneic BCMA CAR-T)**: Data update at ASH2025 with IND submission by year-end 2025 [3] - **KJ-C2219 (allogeneic CD19/CD20 CAR-T)**: Preliminary data sharing expected in 1H26 [3] Investment Thesis - **Product Pipeline**: CARsgen's leading product, zevor-cel, is already launched in China, with potential for global market expansion. The company is also advancing its allogeneic CAR-T programs [8] - **Market Challenges**: The low affordability of treatments in the Chinese market is seen as a significant barrier to achieving peak sales, emphasizing the need for global market access [8] - **Stock Rating**: The stock is rated as "Sell" with a 12-month target price of HK$15.26, reflecting concerns over the current market valuation and the need for positive clinical trial results to justify higher valuations [9][10] Risks and Considerations - **Upside Risks**: Significant progress in US trials, global business development collaborations, and better-than-expected results from allogeneic CAR-T assets could positively impact the stock [9] - **Cash Position**: The company reported Rmb 1.26 billion in cash and equivalents as of June 30, with a goal to maintain cash runway until 2028 [2] Conclusion CARsgen Therapeutics is navigating a complex landscape in the biotechnology sector, with promising growth in its zevor-cel product but facing challenges related to market penetration and affordability. The upcoming catalysts and ongoing focus on allogeneic CAR-T therapies will be critical in determining the company's future performance and stock valuation.

CARVYKTI® Performance and Market Position - CARVYKTI® achieved a 135% year-over-year growth in Net Trade Sales, reaching $369 million in Q1 2025 compared to $157 million in Q1 2024[34] - U S CARVYKTI® sales grew 127% year-over-year and 5% quarter-over-quarter, driven by manufacturing performance and capacity expansion, with 114 activated treatment sites[34] - Outside the U S (OUS), CARVYKTI® sales increased by 219% year-over-year and 65% quarter-over-quarter, fueled by capacity expansion and ongoing launches in various countries[34] - The company aims to double commercial supply in 2025, targeting 10,000 annualized doses by the end of 2025 and 20,000 annualized doses by the end of 2027[37] - CARVYKTI® has demonstrated a 97% success rate in CAR-T cell manufacturing and delivers on-time (or before) 95% of the time[38] Financial Highlights - The company's IFRS total revenue increased from $94 million in Q1 2024 to $195 million in Q1 2025[43] - IFRS net loss was $100916000 in Q1 2025, compared to $59793000 in Q1 2024[57] - Adjusted Net Loss (ANL) improved to $26999000 in Q1 2025 from $85257000 in Q1 2024[57] - Adjusted Net Loss per Share improved to -$007 in Q1 2025 from -$023 in Q1 2024[57] Future Outlook - The company anticipates achieving company-wide profitability in 2026, driven by commercial expansion, manufacturing efficiency, and continued margin expansion[51, 52] - Legend Biotech expects its cash position of approximately $1 billion to fund operating and capital expenditures into Q2 2026[50]