Legend Biotech Corporation (NASDAQ: LEGN) Q2 2025 Earnings | 08/11/2025

Legend Biotech Q2 2025 Earnings Call Summary

Key Highlights:

• Record CARVYKTI Sales: $439M in Q2 (↑136% YoY, ↑19% QoQ), surpassing industry records.

• Global Expansion: 7,500+ patients treated; U.S. sales at $358M, ex-U.S. at $81M (↑4x YoY).

• ASCO/EHA Data: 1/3 of patients progression-free at 5+ years in CARTITUDE-1; OS benefit in all subgroups (CARTITUDE-4).

• Regulatory Wins: FDA removed REMS requirements, reducing post-treatment monitoring (2 vs. 4 weeks).

• Pipeline Progress:

  • LB1908 (Claudin 18.2 CAR-T): Encouraging Phase 1 antitumor activity.

  • LB2102 (DLL3 CAR-T, partnered with Novartis): No dose-limiting toxicities in Phase 1.

• Profitability Path: Operational breakeven for CARVYKTI by end-2025, company-wide profitability in 2026 (ex-FX impacts).

Commercial & Clinical Updates

CARVYKTI (Cilta-cel) Performance

• U.S. Demand: ~60% of use in earlier-line settings (2nd–4th line).

• Ex-U.S. Growth: Launches in Germany, Switzerland, Brazil, and private markets (UK, Israel).

• Manufacturing:

  • 97% success rate, 30-day turnaround time.

  • Raritan expansion approval expected by 2025; Tech Lane (EU production) online late 2025.

Community Oncology Push

• 123 U.S. treatment sites (1/3 community hospitals).

• First community partnership: Virginia Oncology Associates (McKesson network).

• DTC Campaign: Launched to educate patients on CARVYKTI’s survival benefits.

Pipeline & Innovation

• Solid Tumors: LB1908 (Claudin 18.2) and LB2102 (DLL3) show early promise.

• Next-Gen Platforms:

  • TAVEC (T-cell Activation Vector): Targeting autoimmune diseases/NHL; IND studies planned.

  • Philadelphia Research Facility: Focus on in vivo delivery for off-the-shelf therapies.

Financials & Outlook

• Revenue: $255M (↑136% YoY), driven by collaboration revenue.

• Adjusted Net Income: $10M ($0.03 EPS) vs. loss in prior year.

• Cash Position: $1B; on track for 2026 profitability (ex-FX).

• Margins: 57% gross margin on product sales; R&D at 39% of revenue.

2025 Priorities

1. Complete CARTITUDE-6 enrollment (frontline multiple myeloma).

2. Expand manufacturing capacity (Raritan, Tech Lane).

3. Drive earlier-line adoption via community outreach and DTC.

Q&A Highlights

1. CARTITUDE-5/6 Timing: Enrollment on track; interim reads dependent on events/FDA discussions (MRD as endpoint).

2. Safety Profile: No Parkinsonism/GBS in real-world data with strong bridging (e.g., talquetamab). Earlier lines show ↓ neurotoxicity.

3. Competitive Positioning: Unmatched OS data (5-year survival in CARTITUDE-1) vs. immature competitor data.

4. Ex-U.S. Pricing: 30% discount to U.S. expected to persist; EU growth to accelerate with Tech Lane.

5. Capital Allocation: Focus on pipeline (solid tumors, autoimmunity) and manufacturing scalability.

Key Takeaways

• CARVYKTI is the CAR-T market leader, with record sales and practice-changing survival data.

• Community expansion and DTC efforts aim to capture 80K+ 2nd–4th line patients globally.

• Pipeline diversification (solid tumors, next-gen platforms) positions Legend for long-term cell therapy leadership.

• Profitability within reach (2026), backed by $1B cash and operational discipline.