Legend Biotech’s SWOT analysis: carvykti drives growth as stock faces competition

Legend Biotech Corporation (NASDAQ:LEGN) is a biotechnology company focused on developing novel cell therapies for oncology and other indications. The company’s flagship product, Carvykti, has established itself as a leading treatment for multiple myeloma (MM), driving remarkable revenue growth of 74.75% over the last twelve months and attracting investor attention. With a market capitalization of $6.97 billion and notably low market volatility (Beta: 0.26), Legend Biotech presents an intriguing investment case. This analysis examines Legend Biotech’s current market position, growth prospects, and challenges in the evolving landscape of cell therapies.

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Recent Financial Performance and Market Position

Legend Biotech has demonstrated strong financial performance, with Carvykti sales nearly doubling year-over-year in 2024. According to InvestingPro data, the company maintains robust liquidity with a current ratio of 4.71 and holds more cash than debt on its balance sheet. While Legend Biotech’s earnings per share (EPS) remain negative at -$1.77 for the last twelve months, analysts have revised their earnings estimates upward for the upcoming period, with fiscal year 2025 EPS projected at -$0.75, showing improvement from current levels.

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Carvykti’s Q1 2025 sales reached $369 million, exceeding consensus estimates by approximately 5% and showing quarter-over-quarter growth of over 10%. This performance has contributed to Legend Biotech’s stock outperforming both the XBI (biotech index) and SPY (S&P 500) year-to-date in 2025.

Carvykti: Key Driver of Growth

Carvykti, Legend Biotech’s CAR-T cell therapy for multiple myeloma, has emerged as the primary growth driver for the company. The therapy has shown impressive long-term remission results, with data from the CARTITUDE-1 study suggesting a median overall survival of 60.6 months and potential curative effects in 33% of late-line relapsed/refractory multiple myeloma patients.

Analysts project Carvykti sales to reach $1.9 billion in 2025, reflecting strong market demand and successful commercialization efforts. The therapy has gained traction in earlier lines of treatment, with over 50% of uptake in the United States coming from early lines. This expansion into earlier treatment lines is expected to drive further growth, as cure rates and overall survival benefits are anticipated to be higher in these settings.

Pipeline and Future Prospects

While Carvykti remains the cornerstone of Legend Biotech’s current success, the company is actively developing a diverse pipeline to support future growth. Key pipeline candidates include:

1. LB1908: A CAR-T therapy targeting gastric and esophageal cancer, currently in Phase I trials.

2. LB2102: A CAR-T therapy for small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC), also in Phase I trials.

Upcoming data readouts from these pipeline candidates, as well as additional data from the CARTITUDE studies, are expected to provide insights into Legend Biotech’s future growth potential. Analysts view this diverse pipeline as providing optionality for further expansion beyond Carvykti.

Competitive Landscape

Legend Biotech faces competition in the multiple myeloma treatment space, particularly from other BCMA-targeted therapies. The company’s main competitor is Anito-cel, another CAR-T therapy for MM. However, analysts believe that Carvykti maintains a competitive edge due to its established efficacy, improved treatment protocols, and potential for outpatient administration.

Carvykti’s unique cytokine release syndrome (CRS) onset profile allows for 100% outpatient dosing in major academic centers, which could provide a significant advantage over competitors. Additionally, long-term follow-up data and real-world evidence are expected to further differentiate Carvykti from Anito-cel and other competing therapies.

Manufacturing and Supply Chain

Legend Biotech is actively expanding its manufacturing capabilities to meet the growing demand for Carvykti. The company aims to double its supply capacity by the end of 2025, targeting 10,000 treatment slots per year. This expansion is supported by partnerships with Novartis and Johnson & Johnson, as well as the development of in-house manufacturing facilities.

Management has expressed confidence in matching patient demand by year-end 2025, with expansion plans at the Raritan and TechLane facilities progressing on schedule. The company’s diversified manufacturing locations also provide a strategic advantage in navigating potential regulatory and political challenges.

Regulatory Environment and Clinical Data

Legend Biotech has achieved significant regulatory milestones with Carvykti, including FDA approval for later lines of treatment in multiple myeloma. The therapy’s inclusion in the European Medicines Agency (EMA) label, with a statistically significant overall survival benefit, is expected to serve as a promotional tailwind in ex-EU markets.

Upcoming clinical data, including long-term progression-free survival (PFS) results and potential accelerated approval based on minimal residual disease (MRD) endpoints, could further strengthen Carvykti’s position in the market. The company is also focusing on expanding Carvykti’s approved indications, targeting earlier lines of treatment and additional geographical regions.

Bear Case

How might increased competition impact Carvykti’s market share?

As the multiple myeloma treatment landscape evolves, Carvykti faces growing competition from other BCMA-targeted therapies and emerging treatment modalities. Anito-cel, a competing CAR-T therapy, poses a direct threat to Carvykti’s market position. Additionally, the development of bispecific antibodies and allogeneic CAR-T therapies could potentially offer more accessible and cost-effective alternatives to Carvykti.

The increasing competition may lead to pricing pressures and reduced market share for Carvykti, particularly if competing therapies demonstrate comparable efficacy with improved safety profiles or more convenient administration. Legend Biotech will need to continuously innovate and differentiate Carvykti to maintain its competitive edge in an increasingly crowded market.

What are the risks associated with manufacturing expansion plans?

Legend Biotech’s ambitious manufacturing expansion plans, aiming to reach 10,000 treatment slots per year by the end of 2025, carry inherent risks. Scaling up cell therapy production is complex and capital-intensive, requiring significant investments in facilities, equipment, and personnel. Any delays or setbacks in this expansion could hinder the company’s ability to meet growing demand for Carvykti, potentially limiting sales growth and market penetration.

Moreover, maintaining consistent product quality across expanded manufacturing sites can be challenging. Any issues with product consistency or quality control could lead to regulatory scrutiny, production delays, or even product recalls, which would negatively impact Legend Biotech’s reputation and financial performance. The company must also navigate potential supply chain disruptions and ensure a stable supply of raw materials to support its expanded production capacity.

Bull Case

How could expansion into earlier treatment lines boost Carvykti’s sales?

Carvykti’s potential expansion into earlier lines of multiple myeloma treatment represents a significant growth opportunity for Legend Biotech. Currently, the therapy is primarily used in later lines of treatment, but data suggests that Carvykti may be even more effective when used earlier in the disease course. Approval for use in second-line or even first-line treatment could substantially increase the eligible patient population and drive sales growth.

Earlier use of Carvykti is expected to result in higher cure rates and improved overall survival benefits. This improved efficacy in earlier treatment lines could lead to increased adoption by physicians and patients, potentially establishing Carvykti as the standard of care for multiple myeloma. The expansion into earlier lines would also extend the duration of treatment for many patients, further boosting sales and market penetration.

What potential does LEGN’s diverse pipeline offer for future growth?

Legend Biotech’s pipeline extends beyond Carvykti, offering potential for growth in multiple indications. The company is developing CAR-T therapies for gastric and esophageal cancers (LB1908) and small cell lung cancer (LB2102), among others. These pipeline candidates target large market opportunities in areas of high unmet medical need.

Successful development and commercialization of these pipeline assets could significantly diversify Legend Biotech’s revenue streams, reducing reliance on Carvykti and mitigating risk. Moreover, advances in CAR-T technology and manufacturing processes developed for these new therapies could potentially be applied to improve Carvykti or create next-generation treatments for multiple myeloma.

The diverse pipeline also positions Legend Biotech to capitalize on the growing interest in cell therapies across various cancer types. As the company demonstrates expertise in developing and commercializing cell therapies beyond multiple myeloma, it may attract partnership opportunities or become an attractive acquisition target for larger pharmaceutical companies looking to expand their presence in the cell therapy space.

SWOT Analysis

Strengths

• Strong sales growth and market penetration of Carvykti in multiple myeloma
• Established efficacy and potential curative effects in late-line MM patients
• Partnerships with major pharmaceutical companies (Johnson & Johnson, Novartis)
• Expanding manufacturing capabilities to meet growing demand
• Diverse pipeline targeting multiple cancer indications

Weaknesses

• Current negative EPS and reliance on a single commercial product
• Complex and costly manufacturing process for CAR-T therapies
• Limited commercial experience outside of Carvykti

Opportunities

• Expansion of Carvykti into earlier lines of MM treatment
• Geographic expansion into new markets
• Development of pipeline candidates for other cancer types
• Potential for outpatient administration of Carvykti
• Advances in CAR-T technology improving efficacy and reducing costs

Threats

• Increasing competition in the MM treatment landscape
• Potential for new therapies to disrupt the CAR-T market
• Regulatory challenges and evolving reimbursement landscape
• Manufacturing and supply chain risks
• Potential for unexpected safety issues or long-term side effects of CAR-T therapy

Analysts Targets

• Barclays: $94.00 (August 12, 2025)
• BMO Capital Markets: $90.00 (June 2, 2025)
• RBC Capital Markets: $78.00 (June 2, 2025)
• Piper Sandler: $78.00 (May 23, 2025)
• Truist Securities: $71.00 (May 14, 2025)

Legend Biotech continues to attract positive attention from analysts, with price targets ranging from $71 to $94. The consensus view remains bullish, reflecting confidence in the company’s growth prospects driven by Carvykti’s success and pipeline potential. However, investors should carefully consider the risks and challenges facing the company, including increasing competition and the complexities of cell therapy manufacturing and commercialization.

This analysis is based on information available up to August 14, 2025, and investors should continue to monitor Legend Biotech’s performance and market developments for the most up-to-date assessment of the company’s prospects.

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