Legend Biotech: The Onslaught of CARVYKTI Drives Toward Profitability and Global Supremacy

The Oncology Market’s Next Big Bet
In the fiercely competitive arena of oncology therapies, Legend Biotech (LEGN) is positioning itself as a disruptor with CARVYKTI® (cilta-cel), a CAR-T cell therapy for relapsed/refractory multiple myeloma. With Q1 2025 sales soaring to $369 million—a 138% year-over-year leap—and a series of strategic regulatory wins, the company is now at an inflection point. Investors should take note: operational leverage, regulatory momentum, and a fortress-like cash position are aligning to deliver a 2026 profitability turnaround.

CARVYKTI’s Global Surge: Sales Growth and Regulatory Tailwinds

CARVYKTI’s Q1 2025 sales of $369 million mark a pivotal milestone. The therapy has now treated over 6,000 patients, a testament to its efficacy and growing adoption. But sales aren’t just rising—they’re expanding into new markets.

Regulatory Wins Unlock New Markets

• Australia’s TGA Approval: Now cleared for second-line treatment, CARVYKTI can be used earlier in the myeloma journey, doubling its addressable patient pool in Australia.
• EU Label Expansion: The CHMP’s positive opinion to include overall survival (OS) data in the label (from the CARTITUDE-4 trial) strengthens its clinical profile. This is critical for EU adoption, where clinicians prioritize therapies with proven long-term outcomes.

These approvals are game-changers. By moving into earlier treatment lines, CARVYKTI’s market potential expands beyond late-stage myeloma, positioning it as a first-line CAR-T contender.

Manufacturing Scale-Ups: The Key to Profit Margins

CARVYKTI’s one-time treatment model is lucrative, but its profitability hinges on lowering per-unit costs. Enter Legend’s Tech Lane facility in Ghent, Belgium, where clinical production began in Q1 2025.

• Commercial Production by Year-End 2025: This facility will alleviate supply constraints, enabling Legend to meet rising global demand without bottlenecks.
• Cost Efficiency: As production scales, manufacturing costs per dose will drop, boosting gross margins. Current selling expenses (up 69% YoY) are a temporary drag, but they will stabilize as the Belgium plant ramps up.

Cash Runway: A 2026 Turnaround Is Within Reach

Legend’s $1.0 billion cash balance as of Q1 2025 provides a runway through Q2 2026, aligning perfectly with its profitability target. Crucially, the company is de-risking:
- Adjusted Net Loss Narrowing: From $85.3 million in Q1 2024 to $27 million in Q1 2025, signaling operational discipline.
- Reduced R&D Pressure: With CARVYKTI’s clinical trials complete and regulatory approvals rolling in, R&D spend will decline.

Risk vs. Reward: The Calculus for Investors

Risks remain, including manufacturing execution and competition from therapies like BMS’s idecabtagene vicleucel. However, the reward dwarfs the risks:
- CARVYKTI’s Commercial Traction: Over 6,000 patients treated validate its real-world use.
- End-to-End Control: Legend owns manufacturing, commercialization, and distribution—no reliance on partners like Janssen beyond the U.S.
- Free Cash Flow Horizon: With margins expanding and costs under control, positive free cash flow by 2026 is achievable.

Conclusion: A Buy Signal for the Oncology Leader

Legend Biotech is at a strategic inflection point. Its operational leverage (via Belgium’s Tech Lane), regulatory tailwinds (global approvals), and cash runway create a clear path to profitability. With CARVYKTI’s sales surging and execution risks manageable, this is a once-in-a-decade opportunity to invest in a therapy with durable, one-time treatment economics.

Act now: CARVYKTI’s global dominance is just beginning.