Legend Biotech Corp Q4 FY2024 earnings call

• CARVYKTI's unique profile: At the ASH 2024 Annual Meeting, new results from the Phase 3 CARTITUDE - 4 study showed 89% of evaluable patients achieved minimal residual disease negativity with a single infusion of CARVYKTI after a three - year follow - up compared to 38% for standard - of - care. The FDA ODA Committee recommended using MRD negativity as a potential surrogate endpoint in multiple myeloma trials. - Manufacturing and commercial milestones: The FDA approved Novartis facility for commercial production of CARVYKTI in New Jersey. Planning to initiate clinical production at Tech Lane in Ghent, Belgium in the coming weeks and commercial production later this year. CARVYKTI recently received approval for reimbursement in Spain. - Sales performance: Fourth - quarter net trade sales of CARVYKTI were $334 million, up 110% year - over - year and 17% quarter - over - quarter. OUS sales were $31 million, up 138% year - over - year and 15% quarter - over - quarter. - U.S. hospital certification: Total number of U.S. hospitals certified to treat with CARVYKTI is 102, and outpatient administration is a key competitive advantage. - Clinical research: CARTITUDE - 5 is fully enrolled and CARTITUDE - 6 is expected to complete enrollment this year. - Future plans: Work toward doubling CARVYKTI's supply in 2025, include overall survival benefit in CARVYKTI's label, build a new research facility in Philadelphia, and expand pipeline programs to other therapeutic areas.

In the fourth quarter of 2024, net trade sales of CARVYKTI were approximately $334 million, a 110% increase year - over - year and a 17% increase from the third quarter. OUS performance saw sales of $31 million, increasing 138% year - over - year and 15% quarter - over - quarter. The total number of U.S. hospitals certified to treat with CARVYKTI is now 102. CARVYKTI has treated over 5,000 patients, creating the most comprehensive CAR - T patient dataset in multiple myeloma. CARVYKTI contributes significantly to the company's revenue, with its net sales being a major component.

• Anticipate achieving blockbuster status and operational breakeven for CARVYKTI by the end of 2025 and company - wide profitability in 2026, excluding unrealized foreign exchange gains or losses. - Plan to double CARVYKTI's supply in 2025, driven by capacity expansion in Belgium and New Jersey. - Expect growth in 2025 and beyond due to manufacturing and commercial execution and pipeline expansion.

• Potential impact of broad tariffs on Canada, Mexico, and China on manufacturing costs and supply chain. - Obstacles in solid tumor CAR - T development. - Risks related to CARVYKTI's neurotoxicity (e.g., ICANS, MNTs, Parkinsonism) and the need for effective risk mitigation strategies.

Q: Can you give an update on your demand relative to supply? When do you expect that all supply constraints could be potentially alleviated for supply to be able to outpace demand?

A: As we've said before, we're executing well on both the demand and supply. And really by the end of this year, we'll be in a situation where supply is fully meeting the demand where we are and then we'll be able to keep pace with that. The predominant growth will be coming from the existing centers and the referral base into those centers.

Q: Are there any updates on removing fact accreditation to broaden out outpatient CAR - T use?

A: In terms of fact accreditation, the plan that we've heard from some centers is to really do more of an affiliation, where they can be part of an - a fact accreditation umbrella from a larger institution. Rather than removing wholesale, it's more about leveraging the fact accreditation from a larger center.

Q: Can you talk about meeting demand in Europe a little bit more?

A: The demand in Europe is being satisfied by our two facilities in Ghent and in part by Raritan, but more and more we're exclusively going to be supplying it from our Ghent facilities. So, that's Obelisc, and that was approved for commercial use in September of 2024. So, it really is now at this point coming through the holidays just now delivering at full capacity. And then as we mentioned, our Tech Lane facility, which we're continuing to invest in will - we anticipate having commercial approval by the end of 2025. So, between now and end of 2025, to your point, demand is - we're still in a supply constrained environment in Europe and demand is - as demand grows, we're going to work to keep up, but there is a queue in the Ghent facilities to support the European markets. We are working very closely with each center to make sure that we deliver the product when we can. And, overall, across our network, we're increasing reliability, particularly in our Raritan facility where when we have a projected delivery date, 95% of the time we're able to deliver product on or before that delivery date