2025-06-03-Jefferies-传奇生物（LEGN）_Carvykti在ASCO会议上展示5年无进展生存率亮点_安全性改善及生产扩张相关信息_10页_335kb

Legend Biotech Equity Research Summary

• Company Overview: Legend Biotech is a global, clinical-stage biopharmaceutical company specializing in novel cell therapies for oncology. Key product: LCAR-B38M (Carvykti) – a BCMA-targeted CAR-T therapy for multiple myeloma, co-developed with Janssen Biotech.

Clinical Data Highlights:

• Carvykti demonstrated impressive 5-year progression-free survival (PFS) in the CARTITUDE-1 trial, achieving 33% functional cure rate. No maintenance therapy was required in PFS pts.
• Subgroup analyses from CART-4 show consistent PFS and OS benefits across standard- and high-risk cytogenetic patients, with HRs of 0.43 and 0.38 for progression-free and overall survival, respectively.
• Recent ASCO 2025 data underscore sustained efficacy and OS advantages over standard-of-care (SoC).

Risk Mitigation and Safety:

• Neurotoxicity reduced in CART-4 trial (parkinsonism rate from 6% to 1%), aided by adaptive management and key biomarker—absolute lymphocyte count (ALC)—for identifying higher-risk patients.
• Strategies include monitoring ALC daily and using short-course steroids to lower risks, supported by KOL feedback.

Commercial and Manufacturing Updates:

• Revenue target of $1.9B for 2025 is driven by expanding Carvykti use in earlier lines (2-4L) after strong CART-4 data.
• Manufacturing expansion secured with new sites in Belgium (EMA approval expected H2 2025) and New Jersey (FDA approval H2 2025), supporting EU commercialization and physician adoption, particularly due to OS focus in the market.
• Ongoing launch in Spain, Denmark, Belgium, and private UK/Iceland markets.

Financial Projections and Valuation:

• Analysts maintain a "Buy" rating with a price target of $91 (DCF-based, WACC 9.5%), reflecting peak sales estimates of $4.8B.
• Revenue growth expected, with FY 2025 at $991M, and EV/Rev multiple decreasing from 16.4x in 2022A to 4.7x in 2025E.
• P/E ratios decline from 18.9x to 5.4x across forecasted periods.

Risks:

• Identified by analysts include clinical trial uncertainties, regulatory hurdles, manufacturing supply chain issues, commercial viability, competitive threats, and financing challenges. Risks may affect DCF sensitivity, with price targets ranging from $52 to $114 based on various scenarios.