Summary of Legend Biotech Conference Call Company Overview - **Company**: Legend Biotech - **Industry**: Biotechnology, specifically focused on cell therapy - **Key Product**: Carvykti, a CAR-T therapy for multiple myeloma - **Market Position**: World's largest standalone cell therapy company, leading in CAR-T therapy for multiple myeloma [2][3] Core Points and Arguments Financial Performance - Carvykti generated approximately **$1.7 billion** in net trade sales over the last 12 months [3] - The company has a cash position of nearly **$1 billion** and has achieved positive operating profit for Carvykti in Q3 [4] - Legend anticipates achieving company-wide profitability in 2026, with Carvykti expected to generate over **$5 billion** in annual peak sales [5][8] Product Efficacy and Market Penetration - Carvykti has treated over **10,000 patients**, demonstrating a **97% manufacturing success rate** [6][8] - The therapy has shown a **median progression-free survival (PFS)** of nearly **35 months** in heavily pretreated patients [10] - In the CARTITUDE-4 trial, the median PFS has not yet been reached after nearly three years of follow-up [10][44] - Carvykti is the only CAR-T therapy to achieve a **five-year remission survival** in one-third of patients after a single infusion [9] Market Expansion and Strategy - The company is expanding its global presence, with **279 treatment sites** in **14 countries** [6] - A partnership with Johnson & Johnson (J&J) is aimed at maximizing Carvykti's potential, with a **50/50 cost-sharing and profit split** in the U.S. [8] - The company is focusing on community settings, where **70%** of relapsed and refractory multiple myeloma patients are treated [15] Clinical Trials and Future Directions - Ongoing trials (CARTITUDE-5 and CARTITUDE-6) are evaluating Carvykti in newly diagnosed patients, with the goal of addressing an additional **50,000 patients** annually [14] - The company is also exploring allogeneic therapies and in vivo CAR-T programs, with a focus on capital efficiency and rapid clinical proof of concept [21][23] Competitive Landscape - Despite competition in the multiple myeloma market, Legend emphasizes Carvykti's superior survival outcomes and unique one-time treatment benefits [30][37] - The current market penetration for BCMA-targeted therapies is low, with less than **10%** in fifth-line treatments and less than **5%** in second to fourth-line treatments, indicating significant growth potential [13][35] Additional Important Insights - The National Comprehensive Cancer Network (NCCN) has updated guidelines recommending Talvey as a bridging therapy to BCMA CAR-T therapy, which is expected to be adopted quickly [19] - The company has improved its manufacturing turnaround time to below **30 days**, supporting increased supply capacity [31] - The collaboration with J&J includes a **30/70** cost-sharing arrangement for the China market, where Legend leads [32] Conclusion Legend Biotech is positioned as a leader in the CAR-T therapy market for multiple myeloma, with strong financial performance, promising clinical outcomes, and a strategic focus on expanding its market presence and pipeline development. The company aims to leverage its successful R&D model to explore new therapeutic areas while maintaining profitability and enhancing patient outcomes.

Core Insights - Imugene Ltd's cell therapy candidate azer-cel has demonstrated strong response rates in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), achieving an 81% response rate in those who failed autologous CAR-T therapy and an 83% response rate in a newly opened cohort of CAR-T naïve patients [1][4][7] Regulatory and Scientific Milestones - The company is preparing for a meeting with the US FDA in November to discuss the design and regulatory pathway for a planned Phase 2/3 trial, with a detailed briefing document already submitted [2][5] - The data from azer-cel supports potential registration strategies not only in DLBCL but also in other blood cancers such as marginal zone and primary CNS lymphoma [2][4] Presentation and Clinical Confidence - azer-cel will be featured in an oral presentation at the 67th American Society of Hematology Annual Meeting in December, which is significant as oral presentations are peer-reviewed and reserved for highly significant data [3][6][7] - Enrollment in the CAR-T naïve cohort has increased fourfold, indicating growing confidence from clinicians in the azer-cel program [3][7]

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]