Legend Biotech (NASDAQ: LEGN) reported a substantial increase in net sales for its CARVYKTI treatment, marking an 87.6% year-over-year growth to approximately $286 million. This surge also reflects a significant 53.2% rise from the previous quarter. Despite this impressive growth, the company reported a net loss of $125 million, predominantly attributed to unrealized foreign exchange losses. Legend Biotech maintains a strong financial position, with cash and equivalents totaling $1.2 billion, ensuring operational funding into 2026.
CARVYKTI's Clinical Impact and Regulatory Milestones
CARVYKTI has achieved a monumental milestone as the first and only cell therapy to significantly extend overall survival compared to standard of care in patients with multiple myeloma as early as the second line. Specifically, CARVYKTI reduced the risk of death by 45% versus standard therapies after a three-year follow-up period. This achievement positions CARVYKTI as a potentially life-extending treatment option in oncology. The company, along with its collaboration partner, Johnson & Johnson, plans to submit the CARTITUDE-4 overall survival results to regulatory authorities in the U.S. and Europe to update the label with these results.
In the third quarter, CARVYKTI received approval from China's National Medical Products Administration for treatment in the fourth-line plus setting. This approval underscores the global recognition of CARVYKTI's clinical benefits as a one-time infusion. Furthermore, Legend Biotech has expanded its production capabilities in Europe, with commercial production approved at its Obelisc facility in Ghent, Belgium.
Commercial Expansion and Outpatient Treatment
Net trade sales of CARVYKTI reached approximately $286 million in the third quarter, reflecting an 87.6% increase year-over-year and a 53.2% increase quarter-over-quarter. This robust performance aligns with expectations of accelerating growth in the second half of the year, driven by sustained demand and manufacturing efficiencies. OUS sales increased over 100% year-over-year and 35% quarter-over-quarter, supported by increased capacity and ongoing launch expansion. CARVYKTI is now commercially available in Switzerland, marking the fifth country alongside the United States, Germany, Austria, and Brazil.
In the United States, the number of hospitals certified as authorized treatment centers has reached 82. CARVYKTI's unique delayed CRS onset profile allows for extensive outpatient administration, comprising up to 48% of the treatment volume. This outpatient model is a significant growth opportunity, particularly as the company expands into the community setting. CARVYKTI has achieved nearly 90% market share in the BCMA CAR-T class of sales in the U.S. and Germany, establishing itself as the fastest-launching CAR-T product on the market.
Financial Overview and Future Outlook
Total revenues for the third quarter were $160 million, including $143 million in collaboration revenue from CARVYKTI sales and $17 million in license revenue from the agreement with Novartis. The net loss for the quarter was $125 million, or $0.34 per share, compared to a net loss of $62 million, or $0.17 per share, for the same period last year. This increase in net loss was primarily due to unrealized foreign exchange losses of $63 million. As of September 30th, Legend Biotech had $1.2 billion in cash and equivalents, sufficient to fund operations into 2026, when the company expects to achieve operating profitability.
Legend Biotech anticipates sequential revenue growth in the fourth quarter of 2024 and plans to submit overall survival data to the FDA and EMA for potential label updates by the end of next year. The company is also progressing with first-line trials CARTITUDE-5 and CARTITUDE-6 and constructing a new research facility in Philadelphia, expected to be operational in the summer of 2025.
