Legend Biotech Corporation ((LEGN)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Legend Biotech Corporation’s latest earnings call paints a largely positive picture, marked by impressive sales growth, international expansion, and advancements in clinical trials and manufacturing capacity. Despite these achievements, the company faces challenges such as managing neurotoxicity and achieving profitability.
Significant Increase in CARVYKTI Sales
CARVYKTI has seen a remarkable surge in net trade sales, reaching approximately $524 million, which represents an 84% increase year-over-year. Since its launch, the compound annual growth rate (CAGR) has been an impressive 111%, highlighting the product’s strong market performance.
Record Patient Treatment
The adoption of CARVYKTI has been robust, with over 9,000 patients treated, marking it as the strongest CAR-T launch to date. This milestone underscores the therapy’s growing acceptance and success in the market.
Expansion in International Markets
Legend Biotech has achieved significant sales growth outside the U.S., with an increase of nearly fivefold compared to the same period last year. This growth is driven by successful launches in Germany, Spain, and Belgium, showcasing the company’s effective international expansion strategy.
Progress in Manufacturing Capacity
The Tech Lane facility has initiated commercial production to support increased demand in Europe, while expansion at the Raritan facility in the U.S. is progressing as planned. These developments are crucial for meeting the growing demand for CARVYKTI.
Advancements in Clinical Trials
Legend Biotech is making strides in clinical trials, with the initiation of the CARTITUDE-10 Phase II trial and expected completion of enrollment for CARTITUDE-5 and 6 by year-end. These efforts aim to move CARVYKTI into the frontline setting, potentially broadening its application.
Challenges with Neurotoxicity
Despite the successes, the company faces challenges with neurotoxicity. Studies indicate that prophylactic dexamethasone does not reduce the risk of delayed neurotoxicity with CARVYKTI, highlighting the need for effective bridging therapy to manage high tumor burden.
Profitability Not Yet Achieved
Legend Biotech reported a $40 million net loss in Q3, with expectations for company-wide profitability by 2026. This underscores the ongoing challenge of balancing growth with financial sustainability.
Forward-Looking Guidance
Looking ahead, Legend Biotech expects CARVYKTI to achieve profitability by the end of 2025, with company-wide profitability anticipated in 2026. The company is focusing on expanding its manufacturing capacity to meet growing demand, aiming for an annualized capacity of 10,000 doses. Additionally, the FDA has approved an update to CARVYKTI’s label to include an overall survival benefit, based on Phase III CARTITUDE-4 study results.
In summary, Legend Biotech’s earnings call reflects a positive trajectory with significant sales growth and strategic advancements. However, challenges such as neurotoxicity management and achieving profitability remain hurdles to overcome. The company’s forward-looking guidance suggests a continued focus on expanding capacity and market presence, with profitability on the horizon.