Legend Biotech (LEGN) Q4 FY25 earnings call: guidance and Q&A

What are the expectations for CARVYKTI growth in 2026 (US vs. RoW) and what is the business development strategy regarding asset types and stage?

Management is committed to sequential CARVYKTI growth throughout 2026, targeting approximately 50% top-line growth, aligning with Street consensus. Business development focuses on complementary technologies (e.g., non-lentiviral delivery) and potential partnerships for existing in vivo assets to accelerate global development.

“we are planning and also we're committed to sequential growth throughout the year that includes all 4 quarters of 2026. And we have said that we feel reasonably confident of delivering CARVYKTI according to the Street consensus number, which is about 50% top line growth from last year, right?”

asked by Terence Flynn · answered by Ying Huang

How are physicians positioning bispecifics relative to CARVYKTI in early lines post MajesTEC data, and how will growth be driven in these early line settings?

CARVYKTI offers a unique value proposition in earlier lines as a one-time infusion with overall survival and long-term remission benefits. IMWG guidelines support prioritizing CAR-T, as prior bispecific use could diminish CAR-T efficacy. The 2nd and 3rd line segments are the fastest-growing for CARVYKTI, indicating significant unmet need and opportunity.

“We continue to hear very significantly that there is a very unique value proposition for CARVYKTI in these earlier line settings as a one-time infusion, delivering overall survival and 5-year treatment-free remissions in the patients that -- in the later line patients as well.”

asked by Jonathan Miller · answered by Alan Bash

What are the biggest hurdles for continued CARVYKTI expansion in community settings, such as site opening or physician training?

Community hospitals now comprise one-third of activated treatment centers, bringing CARVYKTI closer to patients. Continued education for community physicians is key. The removal of REMS (Risk Evaluation and Mitigation Strategy) has been a significant enabling factor, making physicians more comfortable with local monitoring and increasing referrals.

“I think to your question, it's all about continued education and making sure that the community physicians understand that as they refer patients in, they are going to be getting their patients back without the REMS now in place, and we've heard that again as a significant gating factor that without the REMS in place, more patients can be monitored closer to home.”

asked by Unknown Analyst · answered by Alan Bash

What is the practical target or ceiling for CAR-T penetration in late and early multiple myeloma lines, and is community growth a bigger opportunity than academic centers, especially considering Tec-Dara's potential limitations in community settings?

BCMA-targeting modalities currently have less than 5% market share in the 2nd-4th line setting, indicating vast growth potential. CARVYKTI's efficacy, one-time convenience, and health economic benefits are strong selling points for community adoption. All segments (academic, regional, community practices) represent significant growth opportunities for CARVYKTI.

“if you look at community practice in the second to fourth line setting in the U.S., still all BCMA targeting modalities only account for about 5% market share. That shows us there's plenty of growth for these new regimens in the community setting, right?”

asked by Linhai Zhao · answered by Ying Huang

How will recent M&A in the space (competitor acquired by Gilead) and the non-priority review of their application impact competitive dynamics?

The acquisition validates the value of the multiple myeloma market for autologous CAR-T. The FDA's standard review for a competitor's application (anito-cel) implies a lack of clinical differentiation over existing therapies, which management views as a validation of CARVYKTI's unmatched efficacy and durability. Legend is prepared for any competitive entry, confident in CARVYKTI's data maturity and patient experience.

“Now clearly, based on the FDA determination of standard review, you know the answer, how FDA views this application based on the data supplied in that package. So we feel this is really another validation of that CARVYKTI really has the unmatched efficacy and durability in the field.”

asked by Konstantinos Biliouris · answered by Ying Huang

Is it feasible for CAR-T manufacturers to saturate the market, making it a zero-sum game, and is Legend focused on lentiviral platforms for in vivo efforts or exploring non-viral options?

Management does not believe it's a zero-sum game, with capacity expanding to 20,000 doses to meet growing demand. For in vivo CAR-T, current programs use lentiviral vectors due to in-house expertise, but the company is open to other technologies like LNP through partnerships. Lentiviral vectors also have potential for non-oncology indications if safety is proven.

“So we have accumulated a lot of experience and expertise on this and our first couple in vivo CAR-T programs in the clinic today are using lenti vector as a delivery for the in vivo CAR-T programs in both non-Hodgkin's lymphoma and also the multiple myeloma indications, respectively.”

asked by James Shin · answered by Ying Huang

How does the acceptance of iberdomide NDA on MRD results alter Legend's calculus for potential CARTITUDE-6 filing on MRD results?

While the FDA has a draft guidance for MRD as a registration endpoint, current data correlation is primarily for small molecules and antibodies, not CAR-T. CARTITUDE-5 prospectively includes MRD activity, positioning Legend to potentially be the first to discuss MRD correlation with the FDA for CAR-T. This could accelerate the FDA filing time for CARTITUDE-6, the frontline trial comparing CARVYKTI against stem cell transplant.

“So we might be the first one actually in front of the FDA to discuss the correlation between MRD activity and clinical outcomes such as PFS and survival in the CAR-T trial. And based on that, of course, if FDA agrees, we potentially can accelerate the FDA filing time for CARTITUDE-6.”

asked by Sean McCutcheon · answered by Ying Huang

What is the progress and early signals from trials mitigating delayed neurotoxicity (e.g., Citadel), and when might in vivo program data be seen?

Data from the multicenter Citadel study, investigating ALC monitoring and management approaches for neurotoxicity, is expected this year. Bridging therapy is crucial for mitigating neurotoxic events, with NCCN guidelines updated to include talquetamab as a bridging therapy. The first batch of clinical data for the in vivo program is planned for presentation at a major medical meeting potentially in mid-2026.

“The Citadel study, which is a multicenter study looking at ALC monitoring and then management and treatment approaches should have data presented at some point this year.”

asked by Unknown Analyst · answered by Alan Bash