Legend Biotech Corp (LEGN)

Legend Biotech Corp.: A Comprehensive Overview

Company Profile

History and Background

Legend Biotech Corporation (NASDAQ: LEGN) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for patients with unmet medical needs, particularly in oncology and autoimmune diseases. Founded in 2017, the company has its headquarters in South San Francisco, California, and operates in the United States and China.

Legend Biotech is built on over 20 years of pioneering research on cell therapy by its founders, who were instrumental in the early development of CAR-T cell therapy. The company leverages its proprietary technology platforms, including the BCMA and CD19 CAR-T platforms, to develop a deep pipeline of potentially transformative therapies.

Core Business Areas

Legend Biotech's core business areas are focused on two main therapeutic areas:

• Oncology: The company's lead product candidate, cilta-cel, is a BCMA CAR-T cell therapy currently being investigated for the treatment of relapsed or refractory multiple myeloma (RRMM). Additionally, Legend Biotech has several other CAR-T and other cell therapy programs in its pipeline for various types of cancers.
• Autoimmune Diseases: Legend Biotech is also developing treatments for autoimmune diseases, with its most advanced program being LCAR-B38M, a CD19 CAR-T cell therapy for the treatment of B-cell non-Hodgkin lymphoma (NHL).

Leadership Team and Corporate Structure

Legend Biotech's leadership team comprises experienced individuals with expertise in drug development, clinical research, and business management.

• CEO: Dr. Fang Liang, Ph.D., co-founded Legend Biotech and has over 20 years of experience in the biopharmaceutical industry.
• President and Chief Medical Officer: Dr. Ying Huang, M.D., Ph.D., has extensive experience in leading clinical development programs and regulatory affairs.
• Chief Scientific Officer: Dr. Hongbo Chi, Ph.D., is a renowned expert in cell therapy research and development.

The company's corporate structure is designed to support its global operations and development efforts. Legend Biotech has a research and development center in South San Francisco, a manufacturing facility in Guangzhou, China, and commercial operations in both the United States and China.

Top Products and Market Share

Top Products

Legend Biotech's top product candidate is cilta-cel (CARVYKTI™), a BCMA CAR-T cell therapy approved by the FDA in August 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. This therapy targets the BCMA protein expressed on the surface of MM cells, offering a potentially effective treatment option for patients with limited treatment options.

Market Share

Cilta-cel holds a significant market share in the BCMA CAR-T therapy space for RRMM. As of the first quarter of 2023, it captured approximately 40% of the market share in the United States. However, competition exists from other BCMA CAR-T therapies like Abecma from Bristol Myers Squibb and idecabtagene vicleucel (ide-cel) from Celgene.

Product Performance and Market Reception

Cilta-cel has demonstrated promising clinical efficacy and a favorable safety profile in clinical trials. It received approval based on positive results from the CARTITUDE-1 study, showing a high response rate and durable remissions in heavily pre-treated RRMM patients. The market reception has been positive, with increasing adoption by physicians and growing demand among patients with RRMM.

Total Addressable Market

The global market for multiple myeloma therapies is estimated to be worth around USD 17 billion in 2023, with significant growth potential in the coming years. The market for BCMA CAR-T therapies, a relatively new treatment modality, is expected to grow rapidly, driven by the increasing demand for effective therapies for RRMM.

Financial Performance

Legend Biotech is a pre-commercial stage company, and its financial performance is mainly driven by research and development expenses. As of the first quarter of 2023, the company reported a total revenue of USD 5.1 million, primarily from the commercialization of cilta-cel in the United States. Net loss for the same period was USD 117.3 million, reflecting the ongoing investments in clinical development and commercialization activities.

Dividends and Shareholder Returns

Legend Biotech does not currently pay dividends as it focuses on reinvesting earnings into its growth initiatives. However, the company's stock price has experienced significant growth since its initial public offering (IPO) in June 2021, generating positive returns for shareholders.

Growth Trajectory

Legend Biotech has shown substantial growth over the past few years, driven by the advancement of its lead product candidate, cilta-cel, and the expansion of its pipeline of cell therapy programs. The company plans to continue its growth trajectory by pursuing additional regulatory approvals for cilta-cel in other countries, launching new CAR-T therapies, and expanding its commercial footprint.

Market Dynamics

The cell therapy market is rapidly evolving, with significant advancements in technology and increasing investments from pharmaceutical companies. This market is characterized by intense competition, with several players developing BCMA CAR-T and other cell therapies for various indications. Legend Biotech needs to stay innovative and maintain a strong competitive edge to succeed in this dynamic market.

Competitors

Key competitors in the BCMA CAR-T therapy market for RRMM include:

• Bristol Myers Squibb (BMY): Abecma
• Celgene (CELG): idecabtagene vicleucel (ide-cel)
• Janssen (JNJ): teclistamab

Potential Challenges and Opportunities

Key Challenges

• Intense competition in the CAR-T therapy market
• Regulatory hurdles and uncertainties
• Manufacturing scalability and supply chain challenges
• Managing costs and profitability

Potential Opportunities

• Expanding market share for cilta-cel in existing and new indications
• Launching new CAR-T therapies and cell therapy programs
• Entering new markets and partnerships
• Leveraging technological advancements for further innovation

Recent Acquisitions

Legend Biotech has not made any acquisitions in the past three years (as of November 13, 2023).

AI-Based Fundamental Rating

Based on an AI-based analysis of Legend Biotech's fundamentals, the company receives a rating of 7 out of 10. This rating considers various factors like financial health, market position, growth prospects, and pipeline potential. While the company demonstrates promising growth potential with its lead product, cilta-cel, and a strong pipeline, it still faces challenges in a competitive landscape and needs to navigate regulatory approvals and ensure profitability.

Sources and Disclaimers

This overview is compiled using information from the following sources:

• Legend Biotech website (https://www.legendbiotech.com/)
• SEC filings
• Industry reports and market research
• News articles

Please note that this information is intended for educational purposes only and should not be considered investment advice. Investing in individual stocks carries inherent risks, and it's essential to conduct your own due diligence and consult with a financial advisor before making any investment decisions.