Legend Biotech’s Earnings Call: Growth and Success

Legend Biotech Corporation ((LEGN)) has held its Q2 earnings call. Read on for the main highlights of the call.

Legend Biotech’s Earnings Call Highlights Growth and Regulatory Success

The recent earnings call for Legend Biotech Corporation was marked by a predominantly positive sentiment, driven by notable achievements in CARVYKTI sales and advancements in regulatory and manufacturing capacities. Despite reporting a net loss, the company’s financials showed improvement compared to the previous year, with growth, regulatory advancements, and manufacturing success overshadowing financial lowlights.

Record CAR-T Sales

CARVYKTI net trade sales reached approximately $439 million, marking a 136% increase year-over-year and surpassing the previous CAR-T industry record of $414 million in sales in a single quarter. This milestone underscores the strong market demand and successful execution of sales strategies.

Long-Term Survival Data

CARVYKTI demonstrated a median overall survival of 5 years for patients with heavily pretreated relapsed, refractory multiple myeloma. This sets a new benchmark in this patient population, highlighting the therapy’s efficacy and potential life-extending benefits.

Regulatory Advancements

The FDA’s removal of risk evaluation and mitigation strategies (REMS) for currently approved BCMA- and CD19-directed autologous CAR-T therapies is a significant regulatory advancement. This change is expected to improve patient access and experience, potentially broadening the therapy’s reach.

Manufacturing Success

Legend Biotech’s manufacturing success rate for CARVYKTI remains at an impressive 97%, believed to be the highest in the CAR-T industry. This high success rate is crucial for maintaining supply chain reliability and meeting growing demand.

Global Expansion

CARVYKTI’s sales outside the U.S. grew significantly, with sales of $81 million, which is four times the amount over the same period a year ago and represents a 59% increase quarter-over-quarter. This indicates strong international market penetration and acceptance.

Net Loss and Operational Loss

The company reported a $125 million net loss for the quarter, though this was adjusted to $10 million in net income excluding items not representative of core business. Additionally, the operational loss of $22 million during the second quarter showed improvement from $41 million in the same period a year ago.

Dependency on Regulatory Approvals

Future growth and profitability are contingent upon upcoming regulatory approvals, such as the anticipated approval for manufacturing expansions in Raritan and the Tech Lane facility. These approvals are critical for sustaining growth momentum.

Forward-Looking Guidance

Legend Biotech provided significant guidance during the earnings call. The company anticipates achieving operational breakeven for CARVYKTI by the end of 2025 and company-wide profitability by 2026. The FDA’s removal of REMS for certain CAR-T therapies has reduced monitoring requirements, enhancing patient experience. Additionally, the company is strategically focusing on moving CARVYKTI into frontline settings and investing in solid tumor programs and new research facilities, supported by a robust cash position of approximately $1 billion.

In summary, Legend Biotech’s earnings call reflected a positive outlook with significant achievements in CARVYKTI sales, regulatory advancements, and manufacturing success. Despite financial losses, the company’s strategic initiatives and forward-looking guidance suggest a promising trajectory for future growth and profitability.