Legend Biotech (LEGN) Q2 FY26 earnings call: guidance and Q&A

Update on the in vivo CAR-T BCMA program, particularly with J&J, and when to expect additional information.

Legend will conduct an investigator-initiated clinical study in China for LB2505, a BCMA-targeted in vivo CAR-T therapy for multiple myeloma, subject to the J&J collaboration agreement. Further details will be provided when appropriate.

“Legend will be conducting an investigator-initiated clinical study in China. Evaluating LB2505, which is an investigational BCMA-targeted in vivo CAR-T therapy for multiple myeloma.”

asked by Eric Schmidt · answered by Alan Bash

What is the minimum duration of response needed for confidence in LB2501's durability, and is ASH a reasonable expectation for updated Phase I data?

The company targets sharing 6-month complete response (CR) rate data for LB2501. Updates will be provided at future medical conferences.

“we would be targeting ultimately to be able to share data at the 6-month CR rate. And we will be able to provide updates at future medical conferences in terms of the 2501 program.”

asked by Unknown Analyst · answered by Alan Bash

Given the strong MonumenTAL-6 data for TECVAYLI/TALVEY and commentary on its later-line usage, what feedback is Legend hearing from physicians regarding managing toxicity and sequencing CARVYKTI relative to bispecifics?

Management emphasized CARVYKTI's 'one and done' value proposition, potential for long-term remission, and the benefit of earlier CAR-T use. The discussion with KOLs is about optimal sequencing, with real-world data suggesting better outcomes when CAR-T is used first.

“the data really suggests that earlier is better with CAR-T. You get better efficacy, better safety and improved manufacturing when you get CAR-T earlier and really where the conversation has gone is not really about CARVYKTI versus bispecific. It's really about the sequencing.”

asked by Unknown Analyst · answered by Alan Bash

Why does increasing outpatient volume change gross margin dynamics, and is the plan to achieve large molecule-like cost of goods still on track?

Increasing outpatient volume (now ~60% of mix) introduces various dynamics that could impact gross margin. The company still expects COGS to decline over time, with a clear path to achieving 75% gross margins once all manufacturing nodes are at a steady state.

“once all of our nodes are at a steady state, our gross margins will be in line with what we believe is industry standards of around 75%. And we actually have -- we see a clear path to 75% over time.”

asked by Leonid Timashev · answered by Carlos Santos

What was the motivation behind the recent equity raise, given the company's commitment to profitability?

The equity raise was opportunistic, following strong in vivo data, to provide greater flexibility to accelerate LB2501 development and the broader in vivo platform. This will also provide better business development optionality and strengthens the company's position to fund R&D efforts after repaying the J&J loan.

“The follow-on was an opportunistic equity raise following the strong in vivo data that we presented at EHA. This additional capital really gives us greater flexibility to accelerate the development of LB2501 and our broader in vivo platform.”

asked by Jessica Fye · answered by Carlos Santos

Is the China tax rate a cash payment or accounting, and clarify the J&J loan repayment mentioned in relation to the financing.

The tax provision reflects the expected impact of an agreement, including China and other entities' profitability. The J&J loan of approximately $300 million, which accrued interest, became a current liability this year and is being paid down via cash and profit recoupment, with full settlement expected this year.

“as part of our collaboration agreement, there was a loan of around $300 million and that accrued interest over time that became a current liability this year. So we have been paying down both principal and interest on that loan this year. And it's a combination of cash repayments to J&J as well as recoupment of profits from our collaboration. We expect to fully settle that liability this year.”

asked by Yaron Werber · answered by Carlos Santos

Is the Board focused on a commercial operator or platform CEO, and will Legend develop LB2501 independently or seek partnership?

The Board is conducting a thorough search for a permanent CEO, looking holistically at various qualities. For LB2501, Legend intends to conduct the Phase I themselves, leveraging internal capabilities and financial flexibility, while remaining open to long-term partnership options for the broader in vivo platform to maximize value, speed, and scale.

“our intention is to be able to conduct that Phase I ourselves. We have the capabilities, and we obviously have the financial flexibility and the resources to do that. We continue to remain open to various options around partnership long term across the in vivo platform.”

asked by Konstantinos Biliouris · answered by Alan Bash

How does the J&J partnership impact in vivo development in immune disease, and what are the differences between Legend's in vivo CAR-T platform and Sail's?

The J&J agreement impacts BCMA CAR-T in multiple myeloma. Legend remains interested in autoimmune disease with multiple targets for in vivo CAR-T. Legend's platform is LV-based with clinical data in NHL, distinct from Sail's preclinical circular mRNA and LNP platform, highlighting the industry's excitement for in vivo approaches.

“Sail has a preclinical platform around circular mRNA and LNP. And so that's very different from our program, which is LV-based. And we've also already shown clinical data in a very meaningful market, which is non-Hodgkin's lymphoma.”

asked by Unknown Analyst · answered by Alan Bash

Given the focus on in vivo, when can we expect updates on other autologous or allogeneic CAR-T programs?

While in vivo is prioritized, the allogeneic platform still holds a good place. The company previously provided updates on its G39D program at ASH last year and will continue to provide additional updates in future conferences.

“We previously provided our G39D program in ASH last year, and we continue to provide additional updates in future conferences on that program.”

asked by Edward Tenthoff · answered by Yuhong Qiu

What is the breakdown of CARVYKTI's 2L-4L mix, and how is the company thinking about extending the in vivo platform into solid tumors, particularly with DLL3?

CARVYKTI's 2L-4L mix is now over 70% in the U.S., with 2L and 3L being the fastest-growing segment. For solid tumors, Legend is exploring a range of targets, acknowledging the unique challenges. The DLL3 auto CAR-T data was meaningful, and Novartis will advance that asset.

“our 2L through 4L now comprises 70% in fact, over 70% of our mix in the U.S. And that's exciting because that means that we are making significant progress in getting CARVYKTI to be used earlier in the treatment paradigm.”

asked by Unknown Analyst · answered by Alan Bash