• Net Trade Sales of CARVYKTI: $334 million in Q4 2024, a 110% increase year-over-year and a 17% increase from Q3.
• OUS Sales: $31 million, a 138% increase year-over-year and 15% quarter-over-quarter.
• Total Revenues: $187 million for Q4 2024.
• Net Profit: $26 million or $0.07 per share for Q4 2024.
• Collaboration Cost of Revenue: $69 million for Q4 2024, up from $32 million in the same period last year.
• Research and Development Expenses: $104 million for Q4 2024, compared to $106 million in the same period last year.
• Administrative Expenses: $34 million for Q4 2024, up from $29 million in the same period last year.
• Selling and Distribution Expenses: $49 million for Q4 2024, up from $34 million in the same period last year.
• Adjusted Net Loss: $59 million or $0.16 per share for Q4 2024.
• Cash and Equivalents: $1.1 billion at the end of 2024.

• Warning! GuruFocus has detected 3 Warning Signs with LEGN.

Release Date: March 11, 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 110% year-over-year increase in net trade sales of CARVYKTI, reaching approximately $334 million in the fourth quarter of 2024.
• CARVYKTI has demonstrated a unique clinical profile, being the first and only CAR-T therapy in multiple myeloma to show a survival benefit versus standard of care.
• The company has expanded its manufacturing capacity, with the FDA approving the Novartis facility in New Jersey for commercial production of CARVYKTI.
• Legend Biotech Corp (NASDAQ:LEGN) has successfully increased the number of certified hospitals in the US to 102, enhancing its treatment reach.
• The company is on track to achieve operational breakeven for CARVYKTI by the end of 2025 and anticipates company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses.

Negative Points

• Legend Biotech Corp (NASDAQ:LEGN) reported a net profit primarily driven by an unrealized foreign exchange gain, indicating potential volatility in financial results due to currency fluctuations.
• Research and development expenses remained high at $104 million for the fourth quarter, reflecting ongoing costs associated with pipeline development.
• The company faces competition from upcoming BCMA bispecifics, which could impact CARVYKTI's market share in the future.
• Despite strong sales growth, the company is still in a supply-constrained environment in Europe, which could limit revenue potential.
• Legend Biotech Corp (NASDAQ:LEGN) is investing heavily in expanding its manufacturing capacity, which could strain financial resources if demand projections are not met.

Q & A Highlights

Q: Can you provide more details on the safety profile and plans for trials managing neurotoxicity in a trial-like setting? A: Jessie Yeung, Interim CFO, explained that recent studies using absolute lymphocyte count (ALC) as a predictive biomarker for neurotoxicity are promising. They plan to harmonize ALC cutoffs in ongoing CARTITUDE studies and expect data presentations this year and next. The mitigation strategies are being incorporated into their trials, and they are confident in CARVYKTI's benefit-risk profile.

Q: What are your plans for ASCO this year regarding trial updates or new data? A: An unidentified company representative stated that while they cannot comment until abstracts are officially accepted, both Legend and J&J are excited about potential data presentations at ASCO.

Q: Can you discuss the commercial demand for CARVYKTI and its market uptake? A: Alan Bash, President of CARVYKTI, noted strong receptivity to CARVYKTI's clinical profile and its approval for earlier lines of therapy. They have converted nearly 60% of usage to second through fourth-line populations, indicating strong market uptake.

Q: How should we think about the cadence of revenue growth this year with new capacity coming online? A: An unidentified company representative mentioned that growth will not be perfectly linear. They expect modest growth in Q1 due to seasonality and facility maintenance, with more significant growth in Q2 and Q3 as manufacturing capacity increases.

Q: What is the outlook for CARVYKTI's market share given potential competition in 2026? A: Ying Huang, CEO, expressed confidence in maintaining market leadership due to CARVYKTI's unmatched depth and durability of response, convenience of one-time treatment, and strong efficacy data. They expect the majority of revenue to come from second to fourth-line indications by 2026.

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