Legend Biotech Corp Q3 FY2024 earnings call

• CARVYKTI continued strong momentum with quarter-over-quarter growth of 53% and year-over-year growth of 87%.
• CARTITUDE-4 trial showed overall survival benefit, reducing death risk by 45% after three-year follow-up. Results were well-received at the International Myeloma Society Meeting.
• Received approval for CARVYKTI in China's fourth-line plus study and in Switzerland with label expansion to third line plus.
• Commercial production facility in Ghent, Belgium approved, enabling CARVYKTI supply to Europe.
• CARVYKTI has nearly 90% market share in the BCMA CAR-T class in the U.S. and Germany.
• Appointed Alan Bash as President of CARVYKTI business unit. Alan has extensive oncology leadership experience.
• CARTITUDE-5 is fully enrolled, and CARTITUDE-6 is expected to complete enrollment next year.
• New research facility in Philadelphia to be operational in summer 2025.

The key product segment is CARVYKTI. In the third quarter, net trade sales of CARVYKTI were approximately $286 million, representing an 87.6% year-over-year increase and a 53.2% quarter-over-quarter increase. Overseas (OUS) sales increased over 100% year-over-year and 35% quarter-over-quarter. CARVYKTI contributes primarily to the company's revenue.

• Expect sequential growth in the fourth quarter.
• Plan to submit CARTITUDE-4 overall survival results to regulatory authorities in the U.S. and Europe for label update.
• Anticipate label inclusion of overall survival benefit in the U.S. and Europe by end of next year.
• Reaffirm intention to achieve higher revenue in the fourth quarter compared to the third quarter.

• Unrealized foreign exchange losses due to intercompany transactions and balances between U.S. and non-U.S. legal entities.
• FDA regulation of CAR-T manufacturing facility capacity affecting supply.
• Potential hesitation from clinicians regarding neurotoxicity in earlier lines of treatment.
• Uncertainties in regulatory review timelines for new data submissions.

Q: Regarding the upcoming data update for CARTITUDE-1 comparison to IMAGINE-1, what are key data points investors should focus on?

A: Ying Huang noted IMAGINE-1 patient population is less sick than CARTITUDE-1, and durability (progression-free survival) is key, with CARTITUDE-1 showing nearly 3 years PFS in the last time patient population.

Q: When should we see the OS benefit from CARTITUDE-4 included in NCCN guidelines and labels?

A: Ying Huang stated Legend and Johnson & Johnson plan to submit OS data to regulators soon, expecting label inclusion in the U.S. and Europe by end of next year.

Q: How should we think about quarter-over-quarter growth going into Q4?

A: Ying Huang reaffirmed expectation of sequential growth in Q4 but couldn't provide quantitative guidance.

Q: What about the FDA cap on CAR-T production?

A: Ying Huang mentioned FDA regulates CAR-T manufacturing facility capacity for all CAR-T, not just specific franchises.

Q: How is the shift from inpatient to outpatient use driven?

A: Steve Gavel said it's driven by sites recognizing volume impact and moving to outpatient use where appropriate, with inpatient use in higher-risk populations, and expecting outpatient proportion to continue increasing.

Q: What's the status of the autoimmune program?

A: Mythili Koneru said the trispecific CD19, CD20, CD22 targeting CAR-T for autoimmune indications has opened its first site, with enrollment ongoing, and potential data in 2025.

Q: How to think about competitive dynamics for late-line products?

A: Ying Huang noted regulatory review timelines are long, and Legend will focus on promoting in earlier lines as payers don't cover switching between CAR-T therapies, and outpatient use is a distinct advantage.

Q: What's the status of China launch for CARVYKTI?

A: Ying Huang said it's under discussion with Johnson & Johnson, prioritizing U.S. and Europe, and Legend uses no raw materials from China in U.S. and Europe production.

Q: Any color on secondary primary malignancies and pipeline?

A: Mythili Koneru said no specific FDA discussions yet, and Ying Huang mentioned no higher SPM rate in CAR-T-treated vs standard therapy patients, with focus on allogeneic modalities and autoimmune programs in pipeline.

Q: Why additional follow-up needed for CARTITUDE-2?

A: Mythili Koneru said CARTITUDE-2 frontline patients have prolonged courses, requiring extensive follow-up for metrics like MRD-negative CR.

Q: Drivers of accelerated approval in Belgium?

A: Ying Huang said Obelisc facility approval allows commercial production in Europe, with EMA not regulating capacity, and plan to have over 10,000 doses per year capacity by end 2025. Steve Gavel talked about pivoting to outpatient and community settings for frontline indication engagement.