Net Trade Sales of CARVYKTI: Approximately $369 million, a 135% increase year over year. US Net Trade Sales: $318 million, a 127% increase year over year and 5% quarter over quarter. OUS Sales: $51 million, more than double compared to the same period a year ago, representing a 65% increase quarter over quarter. Total Revenues: $195 million, driven by collaboration revenue growth of 137% year over year. Net Loss: $101 million. Adjusted Net Loss: $27 million, excluding items not representative of the core business. Operating Loss: Reduced from $180 million to $51 million year over year. Gross Margin on Net Product Sales: 63%, improving from 59% in Q4. R&D Expenses: Grew 1% year over year on an IFRS basis. SG&A Expenses: Grew 29% year over year to $72 million on an IFRS basis. Adjusted Diluted Earnings Per Share: Negative $0.07 compared to negative $0.23 for the same period last year. Cash Position: Approximately $1 billion in cash equivalents and time deposits.

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Release Date: May 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

Legend Biotech Corp (NASDAQ:LEGN) reported a 135% year-over-year increase in net trade sales for CARVYKTI, reaching approximately $369 million. The company has treated over 6,000 patients with CARVYKTI, marking it as the strongest CAR-T launch to date. Legend Biotech Corp (NASDAQ:LEGN) anticipates achieving operational break-even for CARVYKTI by the end of 2025 and company-wide profitability in 2026. The company has a strong cash position of approximately $1 billion, which supports its long-term growth and innovation strategies. Legend Biotech Corp (NASDAQ:LEGN) is expanding its manufacturing capacity with facilities in Belgium and New Jersey, aiming to meet increasing global demand.

Negative Points

The company reported a net loss of $101 million for the first quarter, with an adjusted net loss of $27 million after excluding non-core items. There are concerns about the price differential between the US and ex-US markets for CARVYKTI, which could impact global sales strategies. The company faces challenges in penetrating the community setting for CARVYKTI, with some investors questioning the demand and growth potential. Legend Biotech Corp (NASDAQ:LEGN) is still working on reducing manufacturing turnaround times and improving efficiency, despite current progress. The company is navigating regulatory challenges, including the need for FDA approval for capacity expansions and potential impacts from new leadership at CDER.

Story Continues

Q & A Highlights

Q: Can you explain the price differences for CARVYKTI between the US and ex-US markets? Also, what steps are needed for the new Raritan section approval in the second half of 2025? A: The price differential between the US and ex-US is approximately 30%, varying by country. For the Raritan approval, we are confident in achieving FDA approval for capacity expansion based on our filings and the CB30 process. We do not anticipate any delays from the FDA.

Q: How do you plan to penetrate the community market with CARVYKTI, given some investors believe demand is already satisfied? A: There is high demand for CARVYKTI in earlier lines due to its survival benefits. We are increasing investment in educating the community and connecting experts from treatment centers with community physicians. We are also ensuring that patients return to their community physicians for ongoing care, which should encourage community uptake.

Q: What are the key differentiators of your In Vivo CAR-T platform compared to other players in the space? A: Our In Vivo CAR-T platform focuses on T cell recognition mechanisms, engineered lentivirus to reduce non-specific transduction, optimized CAR design, robust CMC processes, and efficient clinical development. These elements differentiate our approach and enhance therapeutic potential.

Q: Can you provide an update on the outpatient administration of CARVYKTI and its impact on infrastructure hurdles? A: Over half of CARVYKTI administrations are now outpatient, which helps overcome infrastructure hurdles like capacity and staff limitations. Our product's safety profile supports outpatient use, and we are working with centers to address apheresis and cryopreservation challenges.

Q: What is the current status of CARVYKTI's use in the Cartitude 4 population, and how do you see this evolving? A: Nearly 60% of CARVYKTI patients come from the Cartitude 4 population. We expect this to increase to about 75% by the end of the year, especially before competitors enter the market. This shift reflects our focus on earlier line treatments.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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