Legend Biotech (LEGN): A High-Growth Biotech Play with Operational Breakeven and Profitability in Sight

Legend Biotech (LEGN) has emerged as a standout player in the oncology innovation space, driven by the explosive growth of its flagship CAR-T therapy, CARVYKTI, for relapsed/refractory multiple myeloma. With a clear strategic roadmap, groundbreaking clinical data, and a manufacturing expansion poised to unlock profitability, the company is now a must-watch stock for investors seeking long-term value in biotech.

Strategic Execution: Scaling Sales and Manufacturing

Legend Biotech's CEO, Ying Huang, has charted an ambitious yet achievable path for 2025. The company's focus on scaling CARVYKTI sales, expanding manufacturing capacity, and optimizing margins aligns directly with its goal of achieving operational breakeven by year-end and company-wide profitability in 2026 Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1].

CARVYKTI's commercial performance has been nothing short of remarkable. In Q2 2025, the therapy generated $439 million in net trade sales, a 136% year-over-year increase, driven by strong demand in earlier treatment lines and international expansion Legend Biotech Q2 2025 slides: CARVYKTI sales surge...^[2]. This follows Q1 2025 sales of $318 million, reflecting 135% year-over-year growth Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1]. The company now treats over 7,500 patients globally with CARVYKTI, a testament to its market penetration.

To meet surging demand, Legend Biotech is doubling its manufacturing capacity. By the end of 2025, it aims to produce 10,000 annualized doses, supported by new production at Raritan (U.S.), Ghent (Belgium), and the Obelisc site Legend Biotech at Morgan Stanley Conference^[3]. This expansion is critical to supporting the therapy's anticipated use in second- to fourth-line treatment settings, where the majority of patients will be treated Legend Biotech to Double Carvykti Manufacturing Capacity in 2025^[4]. The company's robust cash position—$1.0 billion as of June 2025—further underpins its ability to fund operations and capital expenditures into Q2 2026 Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1].

Clinical Differentiation: ASCO 2025 Data Reinforces Market Potential

The therapeutic value of CARVYKTI has been further validated by landmark clinical data presented at the 2025 ASCO Annual Meeting. In the CARTITUDE-1 study, 32 of 97 heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM) remained progression-free for five years or more after a single infusion of CARVYKTI, without maintenance therapy Legend Biotech Unveils Groundbreaking 5-Year Survival Data for CARVYKTI in Multiple Myeloma at 2025 ASCO Annual Meeting^[5]. Notably, these patients had a median age of 60 and included high-risk subgroups with triple-class refractory disease and extramedullary disease (EMD).

The safety profile remains consistent with its known benefit/risk profile, with no new neurocognitive adverse events reported Legend Biotech Unveils Groundbreaking 5-Year Survival Data for CARVYKTI in Multiple Myeloma at 2025 ASCO Annual Meeting^[5]. Subgroup analyses from the CARTITUDE-4 trial also demonstrated superior progression-free and overall survival in high-risk populations, reinforcing CARVYKTI's role as an early-line treatment Legend Biotech Unveils Groundbreaking 5-Year Survival Data for CARVYKTI in Multiple Myeloma at 2025 ASCO Annual Meeting^[5]. These data not only solidify its position as a best-in-class therapy but also open new avenues for label expansion, such as the recent positive CHMP opinion to include overall survival benefits in the European label Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1].

Financials and Profitability: From Losses to Breakeven

Despite record sales, Legend Biotech reported a GAAP net loss of $125 million in Q2 2025, driven by high R&D and G&A expenses. However, the company achieved adjusted net income of $10 million, a significant improvement from the prior year's adjusted loss of $3 million Legend Biotech Q2 2025 slides: CARVYKTI sales surge...^[2]. This divergence highlights the need to focus on non-GAAP metrics, which show a path to profitability.

The CEO has reiterated that operational breakeven for CARVYKTI is achievable by year-end 2025, with company-wide profitability expected in 2026 Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1]. This is underpinned by manufacturing efficiency gains, reduced per-dose costs, and the removal of the REMS program in the U.S., which streamlines patient access Legend Biotech Q2 2025 slides: CARVYKTI sales surge...^[2]. The company has also confirmed 2025 full-year sales growth guidance of 53%-87%, reflecting strong Q3 2024 performance and continued momentum Legend Biotech sees strong growth with CARVICTI sales^[6].

Investment Case: A Must-Watch Biotech Play

Legend Biotech's strategic execution, clinical differentiation, and financial discipline position it as a compelling long-term investment. The company's ability to scale CARVYKTI's commercial infrastructure—activating 114 U.S. treatment sites and expanding globally—ensures it can capitalize on the growing demand for CAR-T therapies Legend Biotech Q1 2025 slides: CARVYKTI sales surge...^[1]. Meanwhile, the $1.0 billion cash runway provides flexibility to navigate near-term losses while building toward profitability.

For investors, the key risks include manufacturing bottlenecks and competition from emerging therapies. However, the five-year survival data and operational milestones suggest Legend Biotech is well-positioned to overcome these challenges. With a clear line of sight to profitability and a therapy that redefines treatment standards in multiple myeloma, LEGN offers a rare combination of high-growth potential and strategic clarity.